MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number CEB231210A

Device Problem Disconnection (1171)

Patient Problems Aneurysm (1708); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The device remains implanted and, therefore, was not available for direct evaluation by gore.It should be noted the instructions for use for the gore® excluder® aaa endoprosthesis and the gore® excluder® iliac branch endoprosthesis state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak and aneurysm rupture.¿.

Event Description

On (b)(6) 2019, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses, gore® excluder® iliac branch endoprostheses and a non-gore manufactured stent graft as a bridging component.On (b)(6) 2021, follow-up examination reportedly identified a pending rupture of the abdominal aortic aneurysm.A distal type iii endoleak (component disconnection) was also reportedly detected between the proximal end of the iliac branch endoprosthesis and the distal end of the non-gore manufactured bridging component.On the same day, the patient underwent an emergency re-intervention procedure whereby a 27mm gore® excluder® contralateral leg component was implanted as an additional bridge leg in the iliac branch endoprosthesis and non-gore manufactured stent.According to the report, procedural imaging showed inadequate seal between the iliac branch endoprosthesis and the 27mm contralateral leg component.Three additional gore® excluder® devices were implanted to reline the stent graft system.The procedure was completed without any further reported complications.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER ILIAC BRANCH 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11886949
• MDR Text Key: 254855547
• Report Number: 3013164176-2021-01182
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: 00733132635290
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2021

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: 12/12/2021
• Device Model Number: CEB231210A
• Device Catalogue Number: CEB231210A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/26/2021
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR