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 Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2020

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment of an arch aorta aneurysm using gore® tag® conformable thoracic stent graft with active control system(ctag-ac).A 24fr sheath was inserted from the right femoral artery.After deploying the ctag-ac to its intermediate diameter, the angulation control dial was rotated about 20 times.Upon fully deploying the ctag-ac, the physician attempted to remove the delivery catheter, however, it could not remove because when the physician slowly moved the delivery catheter , the pus moved together.Reportedly, it seemed like the stent apex was wedged into the olive tip.A gore® molding & occlusion balloon catheter(mob) was inserted, and during the mob was inflated at the proximal side of the ctag-ac, the delivery catheter was moved back and forth.The attempt made successes and the delivery catheter was removed without any further issue.The procedure was continued and the patient tolerated the procedure.Since the delivery catheter was discarded at the facility due to the infectious patient, no device will be returned; however, a customer response letter is required.Base on the provided picture, is it possible to issue a customer response letter?.

Manufacturer Narrative

Additional codes: h6: type of investigation: 3331 analysis of production records; 10 testing of actual/suspected device h6: investigation findings: 213 no device problem found (per review of production records) 170 manufacturing process problem identified (per engineering evaluation, below) h6: investigation conclusions: 25 cause traced to manufacturing the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the device was not returned for physical evaluation.Based on the images and information provided, the reported inability to remove the catheter following deployment was confirmed.Damage was visible to the curved olive that indicated that a proximal apex was wedged between the olive and delivery catheter.A wedged apex can prevent the catheter from disengaging from the device post-deployment.The findings of the evaluation are consistent with the reported event description that a proximal apex was caught on the delivery catheter, preventing the catheter from being removed following deployment.The catheter remaining attached to the stent graft following deployment can be attributed to the proximal apex that was wedged between the catheter and olive, which did not separate during deployment.

Manufacturer Narrative

H6.Code 23 revised from code 25 after engineering evaluation.

• 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: 11059228
• MDR Text Key: 223255251
• Report Number: 2017233-2020-01557
• 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,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2023
• Device Catalogue Number: TGMR373715J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/26/2020; 11/26/2020
• Supplement Dates FDA Received: 02/03/2021; 06/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR