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

Catalog Number	TGMR313120
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Paralysis (1997)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® tag® conformable thoracic stent graft with active control instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, neurologic damage, local or systemic (eg, stroke, paraplegia, paraparesis).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2024, patient underwent an endovascular procedure to treat a dissection utilizing gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2024, patient became paralyzed.A low blood pressure was also observed.Patient was sent to a spinal neuro rehab facility to obtain further treatment.The cause of paralysis is unknown but could be related to the low blood pressure.No further patient information is currently available.
Additional Manufacturer Narrative
- as it is unknown which device is directly implicated in this paralysis event, the following devices will also be included in this report: catalog #tgmr313115/ serial #(b)(6) /udi # (b)(4).
Additional Manufacturer Narrative
After further communication with the fsa, it was reported that the paralysis, stroke, and death was not related to the evar procedure, or gore stents that were implanted.This report shall be retracted.
Event or Problem Description
The following was reported on 1/7/2024: it was later reported that the fsa received additional information from the physician on (b)(6) 2024.Physician reported that on (b)(6) 2024 patient had paralysis on his hands as well.A stroke was also observed.Physician also reported patient was seeing a neurologist.A cyst in the brain was observed sometime after (b)(6) 2024.Neurologist reports the paraplegia and quadriplegia is not related to the gore stents or evar procedure.It was reported the paralysis and stroke patient experienced, was due to an infection in the brain that rapidly progressed.On (b)(6) 2024, patient expired.Physician reports paralysis, stroke, and death is not related to the gore devices or evar procedure and is due to complications from an unrelated brain infection.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20814882
• Report Number: 2017233-2024-05552
• Device Sequence Number: 9934379
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: 00733132646791
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 09/24/2026
• Device Catalogue Number: TGMR313120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 01/07/2025
• Initial Report FDA Received Date: 12/01/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male