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	TGMR373715
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vascular Dissection (3160); Clinical Endoleak (4843)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) state ¿complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to endoleak, dissection, and reoperation.¿ 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
The following was reported to gore: on (b)(6) 2022, the patient presented with a systemic type 3 dissection and underwent endovascular procedure in the descending aorta utilizing two gore® tag® conformable thoracic stent graft with active control system (tgmr373715 and tgmr373710).The patient tolerated the procedure.On (b)(6) 2022, the patient underwent a planned reintervention for an endovascular zone 4 descending thoracic aorta to treat a proximal retrograde type b dissection utilizing a gore® tag® conformable thoracic stent graft with active control system and gore® dryseal flex introducer sheath.Reportedly, patient came in symptomatic through the er with type 1a leak with retrograde b dissection and reintervention was done as there was a fenestration that was not covered on the initial procedure, and it was repaired during the reintervention.Reportedly, the tgmr373715 was most proximal device and immediately adjacent to the retrograde type b dissection and the device was placed in an undissected area in the descending aorta.The reintervention was the cause of the new dissection due to disease progression.The reintervention was successful, and the patient tolerated the procedure.

• 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: 16156891
• Report Number: 2017233-2023-03642
• Device Sequence Number: 7396437
• Product Code: MIH
• UDI-Device Identifier: 00733132646814
• UDI-Public: 00733132646814
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/13/2023

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: 11/02/2024
• Device Model Number: TGMR373715
• 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: 12/30/2022
• Initial Report FDA Received Date: 01/13/2023
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male