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

Model Number	TGMR313115
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment for an acute thoracic aortic type a and b dissection using a gore® tag® conformable thoracic stent graft with active control system endoprosthesis.It was reported that line 3 (which is the red handle) broke when trying to deploy the gore® tag® conformable thoracic stent graft with active control system endoprosthesis, which disengages the catheter from the device.After doing that the physician isolated the line at the back end of the catheter where the handle was supposed to be and tried to pull the line with a hemostat, but could not.The physician then opened up the backup hatch and again isolated line 3 and tried to deploy with a hemostat, but could not deploy, and the line 3 wire broke.As a final attempt, the catheter was cut in half, down closer to the end, and the physician was able to find line 3 with a hemostat and he pulled it out easily.The catheter disengaged from the stent without dislodging the stent or causing any problems.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 213-a review of the manufacturing records for the device verified that the lot met all pre-release specifications.An engineering evaluation was performed.Per the evaluation the delivery system was destroyed at the facility; therefore, no device evaluation could be completed.No potential root cause for the lockwire separating from the lockwire connector or resistance while removing the lockwire could be confirmed since the device was not returned.During testing for design validation, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.Based on the evaluation, the reported difficulty and inability to remove the lockwire could not be confirmed.There is potential that off-label use in an antegrade hybrid fashion may have contributed to the reported event.There is no indication of relation to a manufacturing deficiency.No root cause could be identified as the device was not returned.Addition h6: code 4315.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10165735
• Report Number: 2017233-2020-01000
• Device Sequence Number: 3044800
• Product Code: MIH
• UDI-Device Identifier: 00733132646784
• UDI-Public: 00733132646784
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: TGMR313115
• Device Catalogue Number: TGMR313115
• Device Lot Number: 20925061
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2020
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR