MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU404020J

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

Patient Problems Aneurysm (1708); Aortic Dissection (2491)

Event Date 09/10/2020

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment using gore® tag® conformable thoracic stent graft for thoracic aortic aneurysm.As concomitant procedure, ascending aorta replacement and total debranching were performed.On (b)(6) 2020, a follow-up ct scan image revealed a new aortic dissection.On (b)(6) 2020, the patient underwent reintervention.Intraoperative contrast revealed an entry at out of device treatment area (approx.2 -3 cm distal to device distal edge).The entry was covered using two additional stent graft.The patient tolerated the procedure.

Manufacturer Narrative

Correction due to date of dissection being unknown, this case will not be reportable to the fda per md24757.The medwatch will be retracted for this case.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• 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: 10560670
• MDR Text Key: 207744198
• Report Number: 2017233-2020-01274
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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: 03/19/2022
• Device Catalogue Number: TGU404020J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR