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	TGM343415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/16/2023
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2023 (10:30 p.M.) this patient was transferred from another hospital for treatment of a traumatic thoracic aortic transection.On (b)(6) 2023, (12:30 a.M.) the patient was implanted with a gore® tag® conformable thoracic stent graft with active control system in zone 2.The device was successfully deployed just distal to the left common carotid artery; intentionally covering the left subclavian artery and extended down into the descending thoracic aorta.During close, the patient¿s pressure dropped and the physician re-stuck the patient and advanced a pig tail catheter back up and took 2-3 set of pictures to make sure everything looked good and to confirm no bleeding.All looked good in the thoracic aorta, so the physician took pictures of the abdominal aorta, including the femoral artery and the pelvis area.All looked looked good, with no bleeding seen.The physician checked both thoracic and abdominal aorta multiple times and could see no bleeding or other issues.The patient was closed and the procedure was concluded.On (b)(6) 2023, during another case with the physician he reported that the trauma patient from the previous day had required re-intubation and had been stable, but the patient had expired that morning.The physician reported that treatment on the patient had been based upon the computed tomography angiography (cta) from the transferring hospital.Upon the patient¿s arrival to the emergency room (er) of the treatment hospital (approximately 2 hours later) the er had ordered a new cta but had not made the physician aware of a new cta.Post review of the new cta by the physician it was determined that in the interim between the first and second cta the patient had developed a type a dissection beginning in the ascending arch and extending to the coronary arteries.A cause of death was not provided, there was not device deficiency reported.
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.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16432974
• Report Number: 2017233-2023-03745
• Device Sequence Number: 7326061
• Product Code: MIH
• UDI-Device Identifier: 00733132646968
• UDI-Public: 00733132646968
• 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: 2023
• 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): 02/23/2023

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: 07/25/2025
• Device Model Number: TGM343415
• Device Catalogue Number: TGM343415
• 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: 02/16/2023
• Initial Report FDA Received Date: 02/23/2023
• Date Device Manufactured: 07/27/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 116 KG