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

Catalog Number	PLC121000
Medical Device Problem Codes	Break (1069); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6, investigation findings, code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The device remains implanted.Therefore, an evaluation on the device cannot be performed.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
On (b)(6) 2024, this patient reportedly underwent an emergency endovascular procedure and was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.During the procedure, a gore® excluder® contralateral leg component plc121000 deployed incompletely with 3 cm of the graft remaining closed at its distal end.To overcome the resistance now felt, the physician pulled the line with force which resulted in the deployment line breaking.In an attempt to solve the situation, the physician managed to reach beyond the flow divider of the gore® excluder® ipsilateral leg component and opened the sleeve of the plc121000 component using a balloon.Subsequently, the procedure was concluded as planned.
Additional Manufacturer Narrative
A patient information: replaced gore case ref# (b)(4) with patient identifier.Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, medical device problem code: added code a1501.H6, component code: added codes g04122, g04044.H6, type of investigation: added codes b17, b14, b11.H6, investigation conclusions: replaced code d16 with code d15.The primary reported complaint could not be independently confirmed because there were no items returned for evaluation.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.The reported information indicates additional force was applied to the deployment line to overcome the perceived deployment line resistance.The cause for the initially reported deployment line resistance, resulting in partial deployment of the device, 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.The endoprosthesis remains implanted.The delivery catheter was not available for an engineering investigation.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21117856
• Report Number: 3013164176-2025-02349
• Device Sequence Number: 15373411
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: 00733132618613
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 09/18/2026
• Device Catalogue Number: PLC121000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male