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	TGMR313120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified the lots met pre-release specifications.According to the gore® tag® conformable thoracic stent grafts with active control system instructions for use, adverse events that may occur and / or require intervention include, but are not limited to: neurologic damage, local or systemic.As it is not known which device, if either, were associated with the paralysis, the second device: serial number (b)(4) udi: (b)(4) is also being investigated.
Event or Problem Description
The following was reported to gore: on (b)(6) 2019, the patient presented with a thoracoabdominal aortic aneurysm (taaa) class ii.A staged procedure was started with the implantation of two gore® tag® conformable thoracic stent grafts with active control system.On the same date the patient exhibited left leg paralysis.The patient was treated with a post-operative spinal drain.In-patient physical therapy is currently under way and the patient will be discharged to an in-patient rehabilitation center.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the devices verified the lots met pre-release specifications.Note the previous medwatch should have stated the following: a review of the manufacturing records is currently in progress.

• 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: 10451692
• Report Number: 2017233-2020-01163
• Device Sequence Number: 3656351
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 08/28/2022
• Device Model Number: TGMR313120
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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; Other; Required Intervention
• Patient Age: 71 YR