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	TGM454520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/18/2022
Type of Reportable Event	Death
Event or Problem Description
On an unknown date this patient was implanted with medrtronic devices for treatment of a thoracic aortic aneurysm using a petticoat technique.No additional information is known.On (b)(6) 2022, this patient underwent treatment of a type i-a endoleak associated with the medtronic device(s).A gore® tag® conformable thoracic stent graft and a gore® contralateral leg component were implanted to reline the previous stent grafts.Both devices were successfully placed without issue.During closing the patient coded and expired intraprocedure.The death is believed to be due to a collapse of the left lung.The physician reported all the gore devices performed as intended and there was no device deficiency.The patient had marfan's syndrome but it is unknown marfans contributed to the patient's death.
Additional Manufacturer Narrative
Patient medical history includes but not limited to: marfans syndrome, previous ascending aorta and valve repair, lcca to lsa bypass the instructions for use states, the safety and effectiveness of the gore® tag® thoracic endoprostheses have not been evaluated in the following patient etiologies: previous stent or stent graft or previous surgical repair in the descending thoracic aortic area, genetic connective tissue disease (e.G., marfans and ehlers-danlos syndrome) as no lot number was provided a review of the manufacturing records was unable to be performed, wherefore no udi was generated for the device.
Additional Manufacturer Narrative
D10: patient medications include but are not limited to: melatonin 3 mg qhs prn, metoprolol 25 mg bid, diltiazem sr 120 mg qd, enoxaparin 0.6 ml q 12 hours.

• 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 ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15089345
• Report Number: 2017233-2022-03148
• Device Sequence Number: 14447530
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 07/27/2022

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: 10/31/2024
• Device Model Number: TGM454520
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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: Hospitalization; Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG