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

Catalog Number	TSB081506A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, patient underwent an endovascular procedure to treat a penetrating aortic ulcer utilizing gore® tag® thoracic branch endoprosthesis.On (b)(6) 2024, thrombosis was observed on the thoracic side branch (tsb081506a) via ct scan.Physician performed a carotid subclavian bypass to treat this thrombosis.Date of treatment remains unknown.Physician possibly attributes this thrombosis to a narrowed stent and potential hypotension.Fsa has no further information on this case as he was not present at initial procedure.
Additional Manufacturer Narrative
H6: code c21 - results pending completion of product history review.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.A4-patient weight: this information was requested, but remains unavailable to gore at this time.B7-other relevant history, including preexisting medical conditions: this information was requested, but remains unavailable to gore at this time.C1-cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Images were provided.An imaging analysis was performed, the following was reported: on the (b)(6) 2024 ct there is thrombus visible within the side branch component at the origin of the lsa.On the (b)(6) 2024 ct the side branch is occluded.It should be noted that, per 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, endoprosthesis occlusion and thrombosis.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
Updated g3/g4.Updated h6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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: 19230962
• Report Number: 2017233-2024-04890
• Device Sequence Number: 6732860
• Product Code: MIH
• UDI-Device Identifier: 00733132654383
• UDI-Public: 00733132654383
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/28/2024

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: 12/19/2025
• Device Catalogue Number: TSB081506A
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown