MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TAC083715A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/12/2024
Type of Reportable Event	Death
Event or Problem Description
Fsa called and reported the following: on (b)(6) 2023, the patient underwent a thoracic endovascular procedure to treat an aortic intramural hematoma (imh) that involved the descending thoracic aorta and left subclavian artery.The gore® tag® thoracic branch endoprosthesis (tac083715a, tsb081206a) was utilized in zone 2 to treat this patient.Ct scans showed that the aorta was diseased around the left subclavian artery.The physician decided to land a portion of the tbe aortic component in proximal landing zone, within the diseased tissue.Patient tolerated the procedure.On (b)(6) 2023, the physician called the fsa and reported that the patient developed an ascending imh which she believes caused a stroke and resulted in patient death.Physician believes there may have been thrombus present in the ascending aorta although it was not detectable on ct scan.Physician also speculated that it's possible the ascending imh was induced by the proximal end of the tac083715a since it was landed in diseased tissue.No further patient information is available.No patient images are available.Code 1003-e:-none used to capture no device issue was identified.
Additional Manufacturer Narrative
As it is unknown which device is directly implicated in this death event, the following device will also be included in this report: catalog #tsb081206a/ serial (b)(6)/ udi (b)(4).H6: code c21 - results pending completion of product history review.H6: code c20 - the device remains implanted and, therefore, was not available for engineering analysis by gore.According to the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, neurologic damage, local or systemic-stroke and death.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.
Additional Manufacturer Narrative
As it is unknown which device is directly implicated in this death event, the following device will also be included in this report: catalog#: tsb081206a / serial#: (b)(6) / udi#: (b)(4).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.

• Brand Name: GORE® TAG® THORACIC BRANCH 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
• 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: 18670972
• Report Number: 2017233-2024-04611
• Device Sequence Number: 12822152
• Product Code: MIH
• UDI-Device Identifier: 00733132654116
• UDI-Public: 00733132654116
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 06/17/2026
• Device Catalogue Number: TAC083715A
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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: Death
• Patient Age: 66 YR
• Patient Sex: Unknown