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	TGM343420
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Ruptured Aneurysm (4436)
Date of Event	04/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 and death this event also includes device (b)(4).
Event or Problem Description
On (b)(6) 2022, the patient was treated for a thoracic aortic aneurysm.Three gore® tag® conformable thoracic stent graft with active control system were implanted, and the patient tolerated the procedure.On (b)(6) 2022, the patient was seen for routine followup for staple removal.At that time, the patient complained of back pain.The patient was sent to the er, where they coded, and were unable to be revived.Imaging was performed, and it was seen that there was an aortic rupture, most likely caused by a type i endoleak, although it was impossible to determine which graft had the endoleak, and whether it was proximal or distal.No post-op images are available.According to the physician, the viabhans used as chimneys may have caused a gutter type 1a endoleak.There were viabhans used to chimney celiac, sma and bilateral renals.
Additional Manufacturer Narrative
Added 510(k)/pma number.
Additional Manufacturer Narrative
Added b2: added yes to death and date of death: (b)(6) 2022.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 and death.

• 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: 14462586
• Report Number: 2017233-2022-02948
• Device Sequence Number: 17271936
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: 00733132646975
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2022

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: 11/13/2024
• Device Model Number: TGM343420
• Device Catalogue Number: TGM343420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 06/16/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/03/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female