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	TGM343415
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment for an aortic aneurysm.An elephant trunk technique was being used as well as implanting a gore® tag® conformable thoracic stent graft with active control system.It was reported that while deploying the gore® tag® conformable thoracic stent graft with active control system when the red lockwire handle was utilized the lockwire snapped and separated from the handle.The back up hatch was utilized.The device was implanted successfully and there was no consequences or injury to the patient.The patient tolerated the procedure.Reportedly there was resistance met while attempting to deploy the device.This was an off label case and the device was used outside of instructions for use.The device was advanced bareback over the guidewire through the ascending thoracic aorta while aiming to position the device in the descending thoracic aorta.
Additional Manufacturer Narrative
Review of the event determined this event to be non-reportable.This medwatch will be voided/retracted.

• 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: 10317192
• Report Number: 2017233-2020-01046
• Device Sequence Number: 1073588
• Product Code: MIH
• UDI-Device Identifier: 00733132646968
• UDI-Public: 00733132646968
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 12/04/2020

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: 11/19/2022
• Device Model Number: TGM343415
• Device Catalogue Number: TGM343415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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: Hospitalization
• Patient Age: 57 YR