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 TGMR373720J

Device Problems Malposition of Device (2616); Material Split, Cut or Torn (4008)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/21/2020

Event Type  malfunction  

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 with active control system (ctag ac) for descending thoracic aortic aneurysm.The ctag ac was fully deployed at the target location.No angulation control was used.During removal of lock wire, some resistance was felt, and the lock wire broke.Then, during removal of angulation assembly handle, the angulation fiber broke (1900-e).The access hatch was opened, the lock wire was completely removed using forceps with some resistance.The angulation fiber was also completely removed.Since an attempt was made to remove the angulation assembly handle before the lock wire was completely removed, which resulted in unintended angulation (1934-e) and loss of proximal sealing.A second ctag ac was deployed to extend the device proximally.No adverse event was reported, and the patient tolerated the procedure.The physician stated as follows: there is tortuosity at the diaphragm level.The lock wire of the first device was quite resistant.The lock wire of the second device could be pulled out smoothly without resistance.Please investigate the cause.The reported device will be returned to gore for further investigation.A physician letter was requested.

Manufacturer Narrative

H6: code 3252 - evaluation of returned device revealed broken lock wire.H6: code 4307 - evaluation of returned device revealed broken lock wire.The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the lockwire broke off the lockwire connector.The lockwire was completely removed from the device and catheter.There were kinks in the lockwire approximately 5.5cm and 6cm from the ferrule, likely from removing the lockwire through the back up hatch.The angulation fiber connector was broken, likely due to attempting to remove the angulation fibers prior to removing the lockwire.Based off the device evaluation, the report of the lockwire and angulation fibers breaking could be confirmed.No root cause could be identified for the broken lockwire and angulation connectors.Based on the evaluation, no manufacturing deficiency could be identified.Per md145952 rev.20 no capa request is required.Events will continue to be monitored per md24024.

Manufacturer Narrative

H6: code 4315 cause not established.Original code of 4307 was incorrect.

• 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: 10535605
• MDR Text Key: 207000469
• Report Number: 2017233-2020-01256
• 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: 03/02/2021

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: 01/15/2023
• Device Catalogue Number: TGMR373720J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 08/21/2020
• Supplement Dates FDA Received: 11/30/2020; 03/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR