A Post Market Study to Confirm the Safety and Performance... | NCT03515811

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Abdominal		Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects).	Device: Signia™ Stapling System
Thoracic		Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects).	Device: Signia™ Stapling System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Signia™ Stapling System	Device	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.	Abdominal Thoracic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.	The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: Resulted in a life-threatening illness or injury, or Resulted in a permanent impairment of a body structure or a body function, or In-patient or prolonged hospitalization, or Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.	Up to and including 30 days intra- and post-operative.
The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.	The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in: Resulted in a life-threatening illness or injury, or Resulted in a permanent impairment of a body structure or a body function, or In-patient or prolonged hospitalization, or Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.	Up to and including 30 (+14) days post-procedure.

Secondary Outcomes

Measure	Description	Time Frame
The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.	The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (male or female) between 22 and 80 years of age inclusive at the time of the procedure.
The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent.
The subject is scheduled to undergo an indicated primary abdominal or thoracic procedure for resection, transection and creation of anastomosis per the IFU where the Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads will be used per its IFU.Additionally, if considered appropriate for the procedure only Medtronic buttresses can be used during the course of the study.

3a. Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.

3b. Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB).

Exclusion Criteria:

Subjects undergoing cardiac and vascular procedures.
The procedure is an emergency procedure.
The procedure is a revision/reoperation of a primary operation..
Any female subject who is pregnant. 4a. Females of child-bearing potential will be required to undergo either a urine pregnancy test or serum pregnancy test during Screening and confirmed on the day of operation (except for subjects who are surgically sterile or are post-menopausal for at least two years) (USA only) and per EU local requirements.
Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity).
The subject is unable or unwilling to comply with the study requirements or follow-up schedule.
The subject has comorbidities which, in the clinical judgment of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months.
The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment.
The subject is concurrently enrolled in another investigational drug or device research study or has been enrolled in another study within 30 days of enrollment.
Pre-existing/chronic conditions specific to Tri-Staple™ 2.0 Reload contraindications as described in the IFU.

Name	Affiliation	Role
Kelley Kennedy	Medtronic	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center		Los Angeles	California	90048	United States
Albany Medical College

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 10, 2018	Jan 10, 2022

Arm/Group Information

ID	Title	Description
BG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
BG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00051 BG00185 BG002136

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0019

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001						Percentage and confidence interval	10.6			2-Sided	95	5.0	19.2			95% CI: 5.0%-19.2%		Other
OG000

Primary

The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks.

The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria:

Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in:

Resulted in a life-threatening illness or injury, or
Resulted in a permanent impairment of a body structure or a body function, or
In-patient or prolonged hospitalization, or
Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-procedure.

ID	Title	Description
OG000	Overall	Overall subjects included in the study, in both the thoracic and abdominal indications.

Units	Counts
Participants

Secondary

The Secondary Endpoint is Device Deficiencies/Malfunctions Affecting the Intended Performance of the Device.

The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Secondary

The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Staple Line Integrity (B Formation).

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.

36 subjects had intra-operative assessment data incorrectly recorded for B-formation, so this data was excluded from this part of the intra-operative analysis results. Thus, the overall number of participants analyzed is different for this parameter (44 for abdominal, and 56 for thoracic).

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Secondary

The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Staple-line Bleeding (Measured as > 50 cc) Occurrences.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as > 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.

One abdominal subject died during their study procedure, so the Overall Number of Participants Analyzed in the Abdominal group dropped from 51 to 50 for the intra-operative assessments, since their staple-line was not assessed.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Secondary

The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts

Secondary

The Secondary Endpoint is the Intra-operative Staple Line Assessment Assessing: Number of Intra-operative Leakage.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Secondary

The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Leakage.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts
Participants

Secondary

The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Duration of Air Leakage >7 Days.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered >7 days in duration.

Duration of air leakage was not assessed in the abdominal group, becasue there were no air leaks in the abdominal group.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts

Secondary

The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Post-operative Infection.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts
Participants

Secondary

The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Additional Interventions to Treat Staple-line Failure.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts

Secondary

The Secondary Endpoint is the Post-operative Surgical Site Assessment Assessing: Number of Repeat Hospital Admissions for Primary Procedure-related Complications.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.

Posted

Count of Participants

Participants

Up to and including 30 (+14) days post-operative.

ID	Title	Description
OG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
OG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Abdominal	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Abdominal (approximately 53 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.	1	51	6	51	0	51
EG001	Thoracic	Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri-Staple™ 2.0 Intelligent Reloads. Thoracic (approximately 74 subjects). Signia™ Stapling System: Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.	1	85	21	85	31	85

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Syncope	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (22.0)	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected85 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected85 at risk
Cardiac arrest	Cardiac disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Colitis	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected85 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Bronchial injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Brain injury	Nervous system disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Device leakage	Product Issues	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected85 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0018 events8 affected85 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected85 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected85 at risk

ID	Term
D000007	Abdominal Injuries
D013896	Thoracic Diseases

ID	Term
D014947	Wounds and Injuries
D012140	Respiratory Tract Diseases