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	TGMR373720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 this patient underwent endovascular repair on a type b dissection using conformable gore® tag® thoracic endoprosthesis with active control (ctag/ac).The device was implanted at the level of the carotid artery; however, it was reported that there was insufficient healthy tissue in the proximal landing zone.On an unknown date post procedure, follow up revealed a retrograde dissection into the ascending aorta and innominate artery.At some point between (b)(6) 2020, the patient underwent an open repair to treat the new retrograde dissection.There was no issue found with the ctag/ac during the open repair.No further information was provided.

• 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: 10678026
• Report Number: 2017233-2020-01349
• Device Sequence Number: 3065827
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: 00733132646821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 09/07/2022
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 85