MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU404010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore tag® thoracic endoprosthesis instructions for use, adverse events that may occur include, but are not limited to neurologic damage, local or systemic (e.G., stroke paraplegia, paraparesis).
Event or Problem Description
A new query has been fired: study: (b)(6).Query details: (b)(6).(b)(4).Created by: system.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020 a patient underwent endovascular treatment of an aortic aneurysm in the tambe study.The case included the use of a conformable gore® tag® thoracic endoprosthesis.The patient exhibited spinal cord ischemia the same day which was treated with placement of a spinal drain.Rehabilitation services were provided.On (b)(6) 2020 paraplegia was confirmed and physical therapy is in progress.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• 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: 10702038
• Report Number: 2017233-2020-01366
• Device Sequence Number: 3933878
• Product Code: MIH
• UDI-Device Identifier: 00733132617739
• UDI-Public: 00733132617739
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2021
• Device Model Number: TGU404010
• Device Catalogue Number: TGU404010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 80