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

Catalog Number	PLL161407
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19- a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.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
The following was reported to gore: on (b)(6), 2026, the patient underwent endovascular repair of a zone-9 infrarenal aneurysm utilizing a gore® excluder® aaa endoprosthesis.It was reported that during the procedure, an iliac extender (pll) was malpositioned, resulting in unintentional coverage of the right internal iliac artery.The reporter stated that this occurred while fluoroscopic imaging was magnified, which limited visualization of the true distal radiopaque marker on the iliac extender.Under magnified fluoroscopy, a radiopaque marker intended to indicate the minimum required proximal overlap was mistakenly identified as the distal end marker.As a result, the device was deployed more distally than intended.The issue was recognized after deployment during ballooning, when the distal end of the iliac extender was observed to extend into the external iliac artery.At that time, the device was fully deployed and could not be repositioned.The right internal iliac artery was covered without embolization; no coils or additional procedures were performed to occlude the vessel.The patient was reported to have tolerated the coverage.The left internal iliac artery was widely patent; therefore, the physician elected to leave the device in place.No immediate clinical sequelae were reported.The reporter attributed the event to user error related to radiopaque marker misidentification, rather than device malfunction.

• 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: brittany pettengill ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25086851
• Report Number: 3013164176-2026-03009
• Device Sequence Number: 18774721
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: (01)00733132618767(17)281209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: PLL161407
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAZODONE, ATORVASTATIN, PANTOPRAZOLE, SPIRONOLACT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 89 KG