MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGMR404015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient was implanted with conformable gore® tag® thoracic endoprosthesis with active control system to treat a ruptured thoracic aortic aneurysm.It was reported the patient presented emergently, several cook thoracic endoprostheses were implanted and a conformable gore® tag® thoracic endoprosthesis with active control system (tgmr404015/21875918).The patient tolerated the procedure.On (b)(6) 2020, the patient became unstable and a distal type i endoleak was revealed.The physician reintervened and implanted an additional conformable gore® tag® thoracic endoprosthesis with active control system.The patient tolerated the reintervention and the endoleak was resolved.
Additional Manufacturer Narrative
Addition h6: code 213-a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Addition h6: code 22-according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), ¿adverse events that may occur and/or require intervention include, but are not limited to: endoleak.
Additional Manufacturer Narrative
Addition g5.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10588447
• Report Number: 2017233-2020-01293
• Device Sequence Number: 19590065
• Product Code: MIH
• UDI-Device Identifier: 00733132646845
• UDI-Public: 00733132646845
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: TGMR404015
• Device Catalogue Number: TGMR404015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 09/20/2020; 09/20/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/29/2020; 01/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR