MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS

Catalog Number TGE404020

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

Patient Problem No Information (3190)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reoperation.

Event Description

It was reported that on (b)(6) 2016, the patient presented with a type b complicated aortic dissection (diameter 37.9 mm) that was treated with the implantation of a conformable gore® tag® thoracic endoprosthesis (ctag) distal to the left common carotid artery (z2).It was stated that on (b)(6) 2019, false lumen perfusion in the distal thoracic aorta that was stated to be related to the aortic device or procedure (lesion diameter 56 mm) was identified.Coil embolization of the false lumen was performed on (b)(6) 2019.The patient tolerated the procedure.

Event Description

It was reported that on (b)(6) 2016, the patient presented with a type b complicated aortic dissection (diameter 37.9 mm) that was treated with the implantation of a conformable gore® tag® thoracic endoprosthesis (ctag) distal to the left common carotid artery (z2).It was stated that on (b)(6) 2019, false lumen perfusion in the distal thoracic aorta that was (lesion diameter 56 mm) was identified.Coil embolization of the false lumen was performed on (b)(6) 2019.It was reported that the false lumen perfusion was created by an entry tear distal to the implanted device and that the reported adverse vent and reintervention are not related to the implanted ctag device or the initial procedure.The patient tolerated the procedure.

Manufacturer Narrative

Medwatch #2017233-2020-01353 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Type of Device: GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10682255
• MDR Text Key: 211441624
• Report Number: 2017233-2020-01353
• 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: study
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2018
• Device Catalogue Number: TGE404020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 80