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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/27/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022, this patient presented at the hospital via ambulance from a motor vehicle accident and underwent endovascular treatment of a traumatic transection.It was reported the patient had suffered a tremendous amount of blood loss prior to implant.A gore® tag® conformable thoracic stent graft with active control system was advanced within the true lumen and deployed to 50%; upon doing so the patient¿s blood pressure dropped; complete deployment was then executed and the device was angulated proximally to obtain better seal due to a bird beak along the greater curve.It was reported that the patient was already receiving chest compressions during full deployment of the device.The delivery catheter was removed from the patient and chest compressions were continued.The patient was administered intracardiac epinephrine during this time and chest compressions were continued for approximately 38 minutes.The patient was unable to be stabilized and expired.The physician reports the cause of death was grade 4 blunt aortic injury and blood loss.
Additional Manufacturer Narrative
Code 22: complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to: blood loss, death.
Additional Manufacturer Narrative
H6: code 213 added.
Additional Manufacturer Narrative
Further review of the reported event, determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number2017233-2022-03121 was submitted in error and is hereby retracted.

• 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: 15013200
• Report Number: 2017233-2022-03121
• Device Sequence Number: 14057089
• Product Code: MIH
• UDI-Device Identifier: 00733132646920
• UDI-Public: 00733132646920
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 02/19/2025
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 06/27/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 07/14/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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: Other; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male