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

Catalog Number	RLT351414
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	06/29/2023
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.According to the gore®excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement, endoleaks, endoprosthesis or delivery system: component migration and surgical cut down, bypass or conversion.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) 2023.Axial imaging shows lack of proximal device apposition.The length from the right renal artery to the circumferential proximal device is ~75mm.Diameters of the proximal 15mm of abdominal aorta, distal to the right renal artery, range from ~33mm ¿ 42mm.There is thrombus within this 15mm of abdominal aorta.Reconstruction images confirm thrombus throughout the abdominal aorta distal to the right renal artery.Maximum aaa diameter appears to be 64.3mm x 66.1mm.Cannot confirm 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 procedure to treat an abdominal aortic aneurysm repair utilizing gore® excluder® aaa endoprosthesis (stent graft trunk ipsilateral leg c3, stent graft contralateral leg, and stent graft iliac extender).A week before presenting to emergency room (date unknown), the patient presented for left flank pain.Patient had ct scan at the time which demonstrated a large type 1a endoleak (growth size unknown).Patient was schedule to see the physician the same day and be scheduled for urgent open aneurysm repair but patient never arrived for the clinic visit.On (b)(6) 2023, the patient presented to emergency room (er) for a urgent follow-up and admission after recurrent chest pain for the last 3 days radiating down the left arm.Patient was on aspirin and nitroglycerin and has tenderness over the palpable aneurysm sac and potential asymptomatic aneurysm.Its been persistent but not worsening over the past 2 weeks and an open repair will be needed to treat the type 1a endoleak of aortic graft and along with cardiac work-up done in er for chest pain and surgery planned within 1-2 days.On (b)(6) 2023, the patient underwent a planned open abdominal aortic aneurysm repair via transabdominal approach with bifurcated dacron graft and also had a coronary artery bypass graft surgery (cabg) at the same time.During the procedure, an explant of prior implanted gore® excluder® aaa endoprosthesis devices was done that had presented with persistent type 1a endoleak on the trunk ipsilateral as the main body had slid down into the aneurysm sac (size unknown) that could not be fixed with additional stent grafts as the aorta was too big for aortic extender graft.The patient tolerated the procedure well and without complication.

• 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: 17404454
• Report Number: 3007284313-2023-02662
• Device Sequence Number: 12635894
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 07/27/2023

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: 03/19/2020
• Device Catalogue Number: RLT351414
• 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: 06/29/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2017
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 83 KG