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

Catalog Number	PLC201000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular aneurysm repair (evar) procedure to treat an abdominal aortic aneurysm (aaa) utilizing a gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and two contralateral legs).Prior to procedure, they decided to upsize the main body trunk in order to gain more proximal seal.Procedure ended successfully.On (b)(6) 2024, the patient was brought in for an emergent reintervention to do a revision of prior evar procedure as the right side limb (contralateral leg) had completely pulled out proximally of the common iliac artery (migration distance 2cm or more), therefore, there was no distal seal which resulted in the aneurysm rupture.The common iliac artery was 2.5cm in length and the aaa was massive (size unknown) and biased to left side.The device pulling out is related to the aneurysm size, morphology, and a shorter than average common iliac length.During the procedure, two contralateral legs were used to provide for the distal seal and extension from the flow divider of the main body graft.No endoleaks were noted and used an aortic extender conformable (23cxa) across the ostium of the right internal iliac artery to stop retrograde flow from entering the aaa and/or right common iliac system itself as they were not able to keep a wire/catheter there to coil it.This maneuver was a bailout as an occlusion balloon was up for ½ the procedure on the left side due to blood pressure changes (crashes), therefore, time efficiency was important.The patient is still alive today and procedure was completed successfully.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to endoprosthesis or delivery system: component migration, aneurysm rupture and reoperation.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
Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: the images provided for evaluation are pre-implant images only.Unable to confirm that the device moved proximally after deployment and that the aneurysm ruptured post procedure.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19643282
• Report Number: 3007284313-2024-03344
• Device Sequence Number: 18080345
• Product Code: MIH
• UDI-Device Identifier: 00733132618590
• UDI-Public: 00733132618590
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 08/23/2026
• Device Catalogue Number: PLC201000
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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; Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male