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	TGM454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the conformable gore® tag® thoracic stent graft with active control system instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.In addition, the ifu instructs that the minimum overlap between components must be at least 3 cm (gold band to gold band).
Event or Problem Description
On (b)(6) 2020 this patient underwent endovascular treatment of a thoracic aortic aneurysm using conformable gore® tag® thoracic stent graft with active control system.On (b)(6) 2020, the patient presented with possible type iii component disconnect endoleak.A reintervention was performed whereby two addition conformable gore® tag® thoracic stent graft devices were implanted to treat the suspected endoleak.The reintervening physician suspects the overlap between the two original devices may not have been sufficient, thus contributing to the suspected type iii endoleak.The endoleak was resolved and the patient tolerated the procedure.

• 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: 11127253
• Report Number: 2017233-2021-01582
• Device Sequence Number: 3745294
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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
• Report Date (Section B): 01/06/2021

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: 04/27/2023
• Device Model Number: TGM454520
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR