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	TGM343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with conformable gore® tag® thoracic endoprosthesis with active control system (ctag-ac) to treat a thoracic dissection in zone 0 deployment.It was reported that when the primary deployment line was pulled, the device deployed at 50% and the line came out of the back of the delivery handle.The distal end of the device was not deployed, so the secondary line was deployed, still only partial deployment of device but the device was released from the delivery catheter.The physician used a pigtail catheter and manipulation with a guide wire and was able to deploy the device to full deployment.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition the device was returned to gore histology for an engineering evaluation.Per the evaluation the primary deployment line (pdl) that remained connected to the primary deployment knob measured approximately 92.6cm.This is significantly shorter than the approximate 188.5cm pdl attached to the deployment knob of a fully deployed primary sleeve on a separate 34x34x20 device.Based on the evaluation, the reason for the reported incomplete primary sleeve deployment appears to be that the primary deployment line broke.Based on the information available and the evaluation of the returned device, no root cause could be confirmed.

• 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: 11091233
• Report Number: 2017233-2020-01562
• Device Sequence Number: 19635015
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: 00733132646975
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• 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): 05/04/2021

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: 02/18/2022
• Device Model Number: TGM343420
• Device Catalogue Number: TGM343420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 126