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	TGMR404015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog # rlt281414, serial # (b)(4), udi # (b)(4).Catalog # plc231000, serial # (b)(4), udi # (b)(4).Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).
Event or Problem Description
On (b)(6) 2021 the patient underwent endovascular treatment of a penetrating aortic ulcer with a chronic dissection using a gore® tag® conformable thoracic stent graft with active control system, a gore® excluder® aaa trunk-ipsilateral leg component, and a gore® excluder® aaa contralateral leg component.The procedure was a combined tevar and evar procedure.It was reported that the patient had multiple comorbidities.There were no reported issues with device placement.The patient tolerated the procedure.On (b)(6) 2021 the physician informed the field sales associate that the patient experienced paraplegia about two hours after the procedure.Reportedly the cause of paraplegia is unknown.A spinal drain was placed.The patient is being monitored.

• 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: 12580496
• Report Number: 2017233-2021-02439
• Device Sequence Number: 3398389
• Product Code: MIH
• UDI-Device Identifier: 00733132646845
• UDI-Public: 00733132646845
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: TGMR404015
• Device Catalogue Number: TGMR404015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/05/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR