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

Catalog Number	RLT351416
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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: device is not yet returned to gore.A product history review was completed and review of manufacturing records indicated the lot met all pre-release specifications.H6, b15: images have been provided and are currently being reviewed.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) 2025, the patient underwent a procedure to treat with a gore® excluder® aaa endoprosthesis (rlt351416) an abdominal aneurysm repair [aaa].The physician noticed that after releasing the endoprosthesis, the olive (leading tip) detached from the catheter.Then, he used a gooseneck catheter to catch it and take it out of the gore ® dryseal flex introducer sheath.The evar procedure was completed and the stent graft remains successfully implanted.The patient is doing fine.
Additional Manufacturer Narrative
Updated g3.H3: device evaluation could be performed because the affected device catheter was returned to gore.Imaging results are available for this catheter breaking.H6: type of investigation: code b01 added.Investigation finding: c16 added.C21 no longer applicable.Investigation conclusions: d0301 added.D16 no longer applicable.The olive and catheter was investigated with following result: the manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.Product investigation report - investigation performed and had this result, the reported leading olive separation was confirmed during evaluation of the returned device and through evaluation of the provided photographs and clinical images.The reported information indicates the force applied to the device was not excessive, and this is consistent with the state of the returned device as observed during engineering evaluation: the returned device exhibits no evidence of material transfer between the leading olive and the guidewire lumen to indicate bond creation between the two components.The cause for the separated olive is attributed to a manufacturing deficiency involving insufficient bonding.
Additional Manufacturer Narrative
H6: correction for type of investigation, code b15 was entered inadvertently.The b15 is not applicable and is removed.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marcel martin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21363953
• Report Number: 3007284313-2025-03758
• Device Sequence Number: 8481567
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: (01)00733132618484(17)260528
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2025

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: 05/28/2026
• Device Catalogue Number: RLT351416
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 04/11/2025; Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/08/2025; 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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