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

Model Number PLC271200

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: gore® excluder® iliac branch endoprosthesis iliac branch component - sn (b)(4); gore® excluder® aaa endoprosthesis - sn (b)(4); gore® excluder® aaa endoprosthesis - sn (b)(4).Device remains implanted and is unavailable for manufacturer evaluation.A review of the manufacturing records indicated the lot met pre-release specifications.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.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

It was reported that a patient was treated for a left iliac aneurysm with a gore® excluder® iliac branch endoprosthesis on (b)(6) 2022.The patient tolerated the procedure.On september 19, ct imaging appeared to show that the contralateral leg was separated from or was not placed optimally in the iliac branch component, causing a type iii endoleak.The endoprostheses are planned to be relined on (b)(6) 2022.

Event Description

It was reported that a patient was treated for a left iliac aneurysm with a gore® excluder® iliac branch endoprosthesis on (b)(6) 2022.The patient tolerated the procedure.On (b)(6) ct imaging appeared to show that the contralateral leg was separated from or was not placed optimally in the iliac branch component, causing a type iii endoleak.The type iii endoleak was treated with relining on (b)(6) 2022.An endoleak persisted after the reintervention.It is now thought the patient is presenting with a type ii endoleak.No further reintervention is planned.The patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release specifications.Imaging provided is an arterial phase, post-implant cta.Non-con and delay phases not available.There is < 1 cm of overlap between the distal end of the contralateral limb and the proximal end of the ibe component.There is a contrast-like density present outside of the device, cannot confirm contrast without a non-contrast ct available for comparison.However, if contrast could be confirmed, this would be consistent with the reported type iii endoleak, likely due to the lack of overlap between components.There are patent lumbars present at the level of the implanted device.

• Brand Name: GORE® EXCLUDER® AAA 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15792532
• MDR Text Key: 303626749
• Report Number: 3013164176-2022-01537
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: PLC271200
• Device Catalogue Number: PLC271200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 65 KG