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 TGMR313115J

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Aortic Dissection (2491)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight: asked but unavailable other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, infection (e.G., aneurysm, device or access sites), stent graft migration, and reoperation.

Event Description

It was reported that the patient was scheduled for lung cancer resection surgery and on (b)(6) 2020 a gore® tag® conformable thoracic stent graft with active control system was implanted for treatment of a tumor infiltration prior to the resection surgery.On an unknown date in 2020, the patient underwent the scheduled lung cancer resection.It was reported that the patient's aorta was resected to the level that the gore® tag® conformable thoracic stent graft with active control system could be confirmed visually.On an unknown date in 2020, an infection was observed.It was reported that the route of infection and phlogogenic fungus was unknown.The patient underwent antibiotic medication.On (b)(6) 2020 a bleeding tendency was confirmed and an exam revealed a distal stent graft-induced new entry (d-sine).The physician reported that the patient's vessel may have been weak due to the infection.It was also reported that the gore® tag® conformable thoracic stent graft with active control system appeared to have migrated proximally (distance unknown).An additional tevar procedure was performed.The patient tolerated the procedure.

Manufacturer Narrative

Updated h6: sterilization: the following records were reviewed for this case: serial number (b)(6), finished good work order (b)(4), sterilization batch p43724s43724 (generic wo (b)(4)).A review of the sterilization records indicated the lot met all pre-release specifications.

• 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: 10972397
• MDR Text Key: 220479893
• Report Number: 2017233-2020-01513
• 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: 11/03/2021

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: 09/11/2022
• Device Catalogue Number: TGMR313115J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 82 YR