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

Catalog Number	PLC181000
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient underwent endovascular procedure to treat an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis devices and a gore® excluder® iliac branch endoprosthesis.It was reported that post- op.At the follow up scan, it was determined that the plc device implanted on the right side separated from the iliac branch endoprosthesis and migrated distally approximately 60mm due to the tortuosity in the external iliac.Additionally, a type iii endoleak was noticed.Reportedly, there was no vessel coverage.The physician is planning to reline devices using a plc161100 device.The date of reintervention remains unknown.The patient is doing well.
Additional Manufacturer Narrative
Code f- 28 was used to cover that the physician is monitoring the patient, the event is ongoing and further reintervention was planned.The date of the procedure remains unknown.Code c21- was used to cover that the images were provided for analysis.Investigation is in process.H6: code c19- a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for investigation.It was reported that it was a bilateral case with identical devices used on both sides.It is unknown what device was used on the right side and migrated.Both devices were investigated.Also was used: plc181000/(b)(6) udi# (b)(4).A gore® excluder® iliac branch endoprosthesis (unknown) was reported separately.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.
Additional Manufacturer Narrative
B6: imaging evaluation was attached.Code f- 28 was used to cover that the physician is monitoring the patient, the event is ongoing and further reintervention was planned.The date of the procedure remains unknown.H6: code c19- a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for investigation.It was reported that it was a bilateral case with identical devices used on both sides.It is unknown what device was used on the right side and migrated.Both devices were investigated.Also was used: plc181000/(b)(6), udi# (b)(4).A gore® excluder® iliac branch endoprosthesis (unknown) was reported separately.It was reported that the device separation and distally migration was due to the tortuosity in the external iliac.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23044695
• Report Number: 3013164176-2025-02672
• Device Sequence Number: 10044623
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: (01)00733132618743(17)280112
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: PLC181000
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2025
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male