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

Model Number	TAC083715A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/19/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
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)2023, the patient was treated for a thoracic aortic aneurysm.It was reported that there was pre-existing thrombosis.The physician implanted a gore® tag® thoracic branch endoprosthesis aortic component and side branch component.Shortly after the procedure, the patient suffered a stroke.The physician ran a ct scan and angiogram, and then stented the carotid artery.The patient expired on (b)(6)2023.Images were returned ror evaluation.
Additional Manufacturer Narrative
H6: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications this event also includes device (b)(6).Images were returned for evaluation.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ multiple image sets available for evaluation: pre-implantation cta dated (b)(6) 2023, pre-implantation cta dated (b)(6) 2023, post-implantation cta dated 5/19/2023, and intra-operative angiogram dated (b)(6) 2023.¿ images confirm the presence of thrombus within the thoracic aortic arch extending to the proximal descending thoracic aorta.¿ there is flow throughout the implanted gore® tag® thoracic branch endoprosthesis and the side branch device implanted in the left subclavian artery on the (b)(6) 2023 cta @ 1:10pm.¿ an intra-operative angiogram dated (b)(6) 2023 @ 4:14pm shows a stent implanted in the left common carotid artery.Flow is visualized throughout the stent and in the lcca.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17126352
• Report Number: 2017233-2023-04014
• Device Sequence Number: 20691571
• Product Code: MIH
• UDI-Device Identifier: 00733132654116
• UDI-Public: 00733132654116
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/09/2023

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: 01/02/2026
• Device Model Number: TAC083715A
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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 Sex: Male