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

Catalog Number	RLT281414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	07/22/2024
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 specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: one time point available for evaluation: post-implantation cta dated (b)(6) 2024.Patient presents with one kidney.The length from the right renal artery (rra) to the proximal circumferential device is 126mm, by centerline.Thereby, confirming device migration, as described in the description summary.Aortic diameter just distal to the rra appears to be 29.5mm.Aortic diameter ~8mm distal to the rra appears to be 34.9mm.Aortic diameter 15mm distal to the rra appears to be 37.9mm.There is significant circumferential thrombus within this 15mm of abdominal aorta.The maximum abdominal aortic aneurysm diameter appears to be ~70mm x 76mm, on this time point.Cannot confirm aneurysm growth with one time-point.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) 2019, the patient underwent an endovascular aneurysm repair (evar) and endovascular iliac aneurysm repair (ibe) utilizing gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3, two contralateral legs, and iliac extender) and gore® excluder® iliac branch endoprosthesis (iliac branch component and internal iliac component).On (b)(6) 2024, the patient came in to emergency room with abdominal pain and ct scans were done that showed the trunk ipsilateral graft had migrated distally by 9cm from the renal arteries into the aneurysm sac (unknown size).There is a big type 1a endoleak and the graft had flipped over while pulling the whole graft down into the aorta and aneurysm sac.Physician believes that its due to disease progression at the proximal seal zone that led to the migration of the graft.On (b)(6) 2024, the patient underwent endovascular reintervention in zone 9 infrarenal with realignment of the original main body graft with gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and two contralateral legs).Procedure ended successfully.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.Removed h6: d1002 - adverse event related to 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: 19971797
• Report Number: 3007284313-2024-03425
• Device Sequence Number: 12526924
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/06/2024

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: 02/17/2021
• Device Catalogue Number: RLT281414
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2018
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 68 KG