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 TGMR404020J

Device Problem Unintended Movement (3026)

Patient Problem Vascular Dissection (3160)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains implanted and is not available for investigation.Further information was requested but was not available.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, endoprosthesis migration and reoperation.

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of a type b aortic dissection using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2021, a distal migration (distance unknown) and ulcer-like projection (ulp) forming were observed.On (b)(6) 2021, a reintervention placing additional gore® tag® conformable thoracic stent grafts with active control system was performed.The patient tolerated the procedure.It is unknown what caused the device migration.Also, the cause of the ulcer-like projection (ulp) forming is unknown.Further information was requested but was not available.

Event Description

On (b)(6), 2020, the patient underwent endovascular treatment of a type b aortic dissection using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6), 2021, a distal migration (distance unknown) and a distal stent graft-induced new entry(dsine) were observed.On (b)(6), 2021, a reintervention placing additional gore® tag® conformable thoracic stent grafts with active control system was performed.The patient tolerated the procedure.It was reported that the device migrated since some space was created due to the dissociation.

Manufacturer Narrative

Additional information: b5: event description.

• 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: 11780757
• MDR Text Key: 264414157
• Report Number: 2017233-2021-01955
• 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
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Catalogue Number: TGMR404020J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 76 YR