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

Catalog Number TGMR373715J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/13/2020

Event Type  Injury  

Event Description

The following was reported to gore; on (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic aneurysm impending rupture using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2020, a follow-up exam revealed an endoleak.The physician suspected the type ii endoleak first, but any inflow from the branch vessel was not observed.The physician suspected the proximal type i endoleak, the distal type i endoleak or the type iiib endoleak because the patient artery was severe calcificated, and decided to perform a reintervention.During the reintervention procedure, there was something wrong with the c-arm.The digital subtraction angiography (dsa) was not able to be performed and the type of endoleak was not able to be confirmed.Two gore® tag® conformable thoracic stent graft with active control system were implanted as extended the initial device to the proximal and the distal.It was unknown the endoleak still remained or resolved because the dsa was not able to be performed.The physician decided to monitor it.The patient tolerated the procedure.

Manufacturer Narrative

H6: code 3331, added as product history review was completed.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications; h6: code 22 ¿ according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10817145
• MDR Text Key: 215526074
• Report Number: 2017233-2020-01436
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Catalogue Number: TGMR373715J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR