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

Model Number	TGU343415
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical history includes but is not limited to: coronary artery disease, hypercholesterolemia, hypertension, tobacco use, open aaa repair, coronary artery stent and iliac artery stent.The instructions for use (ifu) states, the safety and effectiveness of the gore® tag® thoracic endoprosthesis have not been evaluated in the following patient etiologies: penetrating ulcers, dissections of the descending thoracic aorta.Additionally, the ifu states, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, 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.
Event or Problem Description
On (b)(6) 2013, this patient underwent treatment of a penetrating aortic ulcer, a type b uncomplicated aortic dissection and an intramural hematoma.A conformable gore® tag® thoracic endoprosthesis was implanted within the descending thoracic aorta.The patient tolerated the procedure.On (b)(6) 2013, a new onset descending aortic dissection was identified distal to the device.The physician is monitoring the patient with serial cta.On (b)(6) 2022, a new aortic dissection was reported for the patient.The patient underwent reintervention this date, and an additional aortic endograft was implanted.The information indicates the patient expired this date and that the event was not related to the device or the procedure.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15440065
• Report Number: 2017233-2022-03325
• Device Sequence Number: 5582261
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: 02/29/2016
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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: Other; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White