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

Catalog Number	PLA230300
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient identifier reflect the w.L.Gore internal case number.H3: gore has not received the device yet.As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.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 or Problem Description
It was reported to gore that on (b)(6) 2024, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was therefore treated with gore® excluder® aaa endoprostheses.When delivering a gore® excluder® aortic extender component pla230300 below the left renal artery, the distal portion reportedly separated.Subsequently, the device was retrieved from the patient, resulting in prolonged operative time.
Additional Manufacturer Narrative
H3: the device catheter was received at gore, inspected only the catheter from the device.Updated g3 and d9.Device engineering investigation and conclusion: gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The reported failure mode that the distal portion separated was confirmed through an evaluation of the returned device.The leading end of the catheter (polyimide) had been separated from the trailing olive; however, indentations were observed on the trailing olive indicating the polyimide had been previously bonded.In addition, it was reported that the separation occurred during delivery, but elongation of the trailing olive is consistent with a tensile failure and the endoprosthesis was not returned.The root cause of the separated distal portion could not be established with the available information.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Code a0401 changed to a040102, due to the evaluation result of the affected goods the a040102 fits better to the event.The available information reported in the complaint does not suggest a potential malfunction.The gore® excluder® aaa endoprosthesis ifu was reviewed with respect to the complaint detail.The ifu provides the following warning do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter breakage or separation resulting in potential patient harms, see potential device or procedure-related adverse events.

• Brand Name: GORE® EXCLUDER®AAA ENDOPROSTHESIS
• Common Device Name: 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: marcel martin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21089262
• Report Number: 3013164176-2025-02343
• Device Sequence Number: 18376444
• Product Code: MIH
• UDI-Device Identifier: 00733132618750
• UDI-Public: 00733132618750
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2026
• Device Catalogue Number: PLA230300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown