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

Model Number CEB231210A

Device Problems Migration (4003); Separation Problem (4043)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

According to the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, component migration.

Event Description

On (b)(6) 2016, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system, two gore® excluder® aaa endoprostheses, and two gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.On an unknown date, during a followup, it was observed that the distal end of the contralateral leg component had retracted up into the aneurysm in the left common iliac, causing a distal type i endoleak.It was reported that aneurysm growth of an unknown amount had been seen over the 12 months prior to the followup.On (b)(6) 2020, the patient was treated for the type ib endoleak as the distal end of the gore® excluder® aaa endoprosthesis featuring c3® delivery system.The physician implanted a gore® excluder® iliac branch endoprosthesis and two gore® viabahn® vbx balloon expandable endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, during a follow up visit, imaging revealed that the gore® excluder® iliac branch endoprosthesis and one of the vbxs had separated, and there was a type iii endoleak.A reintervention is planned.

Manufacturer Narrative

H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications - corrected from code 3207.H6: code 4315 - corrected from code 22.H6: code 4043 - corrected from code 4003.H6: code 4625 - added as fda codes were changed after the initial medwatch was submitted.

• 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
• MDR Report Key: 10809432
• MDR Text Key: 215307201
• Report Number: 3013164176-2020-01076
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635290
• UDI-Public: 00733132635290
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 12/03/2022
• Device Model Number: CEB231210A
• Device Catalogue Number: CEB231210A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 03/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84