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

Catalog Number	TGMR373715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event also includes device 26551158/ 00733132646807 images were returned for evaluation.The imaging evaluation stated: ¿ two time-points available for evaluation: pre-implantation cta dated 11/09/2023 and post-implantation cta dated (b)(6) 2023.¿ on the pre-implantation imaging: there appears to be imh vs.Thrombus in the ascending thoracic aorta.The disease in the descending thoracic aorta appears to present as a historical imh finding to the level of the celiac artery.¿ on the post-implantation imaging: there is a tear in the ascending aortic arch just proximal to the proximal implanted device.The tear is located ~17cm proximal to the lsa distal border.The imh just proximal to the celiac artery on the pre-implantation imaging appears to be resolved on the post-implantation imaging.Finding of dissection just proximal to the proximal implanted device in the thoracic aortic arch.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 dissection.The physician implanted two gore® tag® conformable thoracic stent graft with active control systems.The patient tolerated the procedure.On 16-nov-2023.The fsa was informed that the patient was experiencing bleeding, either from a type ia endoleak or a dissection of a intramural hematoma.A gore® tag® thoracic branch endoprosthesis side branch device was implanted.The bleeding was repaired, and the patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Investigation findings: code c21 updated to code c19 with completion of phr review h.6.Investigation conclusions: code d16 updated to code d15 and d12 h6: code 22 ¿ according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18310539
• Report Number: 2017233-2023-04468
• Device Sequence Number: 6278104
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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): 01/02/2024

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: 01/08/2026
• Device Catalogue Number: TGMR373715
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male