MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGU262110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2011 this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The devices were implanted to create an aorto-uni-iliac configuration.On (b)(6) 2021, during follow up, it was discovered that the device had migrated distally, and a type i proximal endoleak as present.On (b)(6) 2021 a reintervention occurred whereby a contralateral leg component was implanted 4cm distal to the lowest renal artery, and a trunk-ipsilateral leg endoprosthesis was implanted at the level of the lowest renal artery.The endoleak was resolved and the patient tolerated the procedure.
Event or Problem Description
On (b)(6) 2011, this patient underwent endovascular treatment of an abdominal aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis (ctag) and a gore® excluder® aaa endoprosthesis contralateral leg component.The devices were implanted to create an aorto-uni-iliac configuration.On (b)(6) 2021, during follow up, it was discovered that the ctag device had migrated distally, and a type i proximal endoleak was present.On (b)(6) 2021, a reintervention occurred whereby a contralateral leg component was implanted 4cm distal to the lowest renal artery, and a trunk-ipsilateral leg endoprosthesis was implanted at the level of the lowest renal artery.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
H10/11: corrected data - b4: description of event (initial report indicated that patient was treated with a gore® excluder® aaa endoprosthesis only.Corrected description to indicate patient was treated with a conformable gore® tag® thoracic endoprosthesis (ctag) and a gore® excluder® aaa endoprosthesis contralateral leg component to create an aui.
Additional Manufacturer Narrative
Investigation findings and investigation conclusion codes.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13118173
• Report Number: 2017233-2021-02650
• Device Sequence Number: 19989657
• Product Code: MIH
• UDI-Device Identifier: 00733132617791
• UDI-Public: 00733132617791
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022

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: 08/31/2014
• Device Model Number: TGU262110
• Device Catalogue Number: TGU262110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021; 12/08/2021
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/19/2022; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2011
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male