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

Catalog Number CEB231410A

Device Problem Patient Device Interaction Problem (4001)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

H6: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications h6: code d12 ¿ 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, endoleak w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

On (b)(6) 2021, the patient was treated for an abdominal aortic aneurysm.The physician implanted a competitor's device, along with a gore® excluder® iliac branch endoprosthesis branch component ceb231410a, and two gore® excluder® iliac branch endoprosthesis internal iliac components, hgb161407a and hgb161207a.The patient tolerated the procedure.On 27-mar-2024, a type ib endoleak was noted from the competitor's device in the left limb, and a gore® excluder® iliac branch endoprosthesis branch component 231410a was implanted.The physician stated that the endoleak was due to competitor device not being well apposed.In addition, the competitor device in the right limb had migrated proximally, and was no longer inside the gore ceb, creating a type iii endoleak.A competitor's device was placed inside the gore device and sealed the endoleak.The patient tolerated the procedure.

Manufacturer Narrative

Added g3/g4, h1/h2, and h6.H6: investigation conclusions: d1001 updated to d1101: according to the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak: improper component placement, component migration.Read all instructions carefully.Failure to properly follow the instructions, warnings, and precautions may lead to serious surgical consequences or injury to the patient.The safety and effectiveness of the gore® excluder® iliac branch endoprosthesis have not been evaluated in the following patient populations: - leaking: pending rupture or ruptured aneurysms - pseudoaneurysms resulting from previous graft placement - revision of previously placed stent-grafts.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19154487
• MDR Text Key: 340796427
• Report Number: 3013164176-2024-02045
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635306
• UDI-Public: 00733132635306
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/22/2024

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: 08/04/2023
• Device Catalogue Number: CEB231410A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: 80 YR
• Patient Sex: Male