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

Catalog Number	RMT281418
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc201200/11086813, udi: (b)(4).The imaging evaluation performed by a clinical imaging specialist showed the following: there are 2 radiographic jpeg images and a post-implantation cta dated 4/15/2026 available for evaluation.The length from the right renal artery (lowest renal)) to the tip of the implanted device appears to be 22mm, by centerline.The length from the rra to the circumferential proximal end of the implanted device appears to be 31.4mm ¿ 34.5mm.(centerline (avg) length ¿ maximum length) (these findings do not demonstrate the historical proximal device landing zone per ifu.) proximal diameters within the 15mm of abdominal aorta distal to the rra appear to range from 26.6mm ¿ 30.5mm, by average diameter.(27.2mm ¿ 31.4mm, by max diameter) these diameters align with the fsa annotated 3d images starting on page 9.The device implanted treats diameters ranging from 24mm ¿ 26mm, suggesting the size of the aorta has changed.There appears to be significant thrombus within this 15mm of aorta and throughout the abdominal aorta.These findings suggest disease progression since the gore® excluder® aaa endoprosthesis was implanted in 2013.These findings also suggest distal device migration since 2013, as per the description summary.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 have not 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) 2013, this patient underwent endovascular treatment of for an unknown etiology and was implanted with gore® excluder® aaa endoprosthesis devices.The patient tolerated the procedure.On (b)(6) 2026, the patient underwent computed tomography which determined distal migration of the devices (distance unknown).On (b)(6) 2026 the patient undersent reintervention and two gore® excluder® conformable aortic extender devices and a gore® excluder® aaa endoprosthesis were implanted along with endo anchors to restore coverage up to the renal arteries.The device migration is attributed to disease progression and thrombus identied by the images provided.The patient tolerated the procedure with good results.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25165299
• Report Number: 2017233-2026-07495
• Device Sequence Number: 21493596
• Product Code: MIH
• UDI-Device Identifier: 00733132610730
• UDI-Public: (01)00733132610730(17)160831
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Expiration Date: 08/31/2016
• Device Catalogue Number: RMT281418
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2013
• 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; Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male