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

Model Number TGU262110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 07/14/2021

Event Type  Injury  

Event 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 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.

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.

Manufacturer Narrative

Investigation findings and investigation conclusion codes.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• Type of Device: 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
• MDR Text Key: 283441149
• Report Number: 2017233-2021-02650
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132617791
• UDI-Public: 00733132617791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: TGU262110
• Device Catalogue Number: TGU262110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 12/08/2021
• Supplement Dates FDA Received: 01/19/2022; 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male