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

Model Number	TGM262610
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted that the gore® tag® conformable thoracic stent graft with active control system instructions for use state, "complications associated with the use may include but are not limited to: improper stent graft placement and branch vessel occlusion or obstruction".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) 2022, this patient underwent emergency endovascular treatment of a traumatic thoracic aortic transection resulting from a motor vehicle accident.A conformable gore® tag® thoracic endoprosthesis with active control was inserted and advanced to just below the carotid artery.The proximal uncovered stent apices were placed at the ostium of the left common carotid artery, and the stent graft was deployed.However, the fabric sleeve of the device fully covered the 9mm ostium of the carotid artery after deployment, and impeded flow into the left common carotid artery.To treat, the physician advanced a mob catheter and inflated it at the proximal and middle portions of the stent graft and was able to pull the stent graft distal to uncover the left common carotid artery and restore blood flow.The patient tolerated the procedure.The fsa noted that the sleeve at the proximal end of the stent graft seemed longer than 4mm.The review of the manufacturing records for the device verified the lot met all pre-release specifications.A response regarding this event was not requested by the physician.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15164315
• Report Number: 2017233-2022-03185
• Device Sequence Number: 2200220
• Product Code: MIH
• UDI-Device Identifier: 00733132646920
• UDI-Public: 00733132646920
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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: 11/29/2024
• Device Model Number: TGM262610
• Device Catalogue Number: TGM262610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2022
• Initial Report FDA Received Date: 08/04/2022
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male