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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/10/2024
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.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, endoleak 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.
Event or Problem Description
The following was reported to gore: on (b)(6) 2017, the patient underwent an endovascular procedure utilizing gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and three contralateral legs).On (b)(6) 2024, the field sales associate was notified by the nurse (rn) that the patient has a suspected type 2 endoleak.An angiogram will be done next week to try and determine what type of leak it is.On (b)(6) 2024, the patient underwent an angiogram to determine the type of endoleak, physician suspected it to be a type 1a or 2 endoleak but they were unable to confirm.There was also aneurysm growth of 7.9cm.During the same day, as they were unable to confirm either type 1a or 2 endoleak, physician did a reintervention by extending proximally from the trunk ipsilateral leg c3 with a gore® excluder®aaa endoprosthesis (aortic extender) which resolved the suspected type 1a endoleak.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: images provided are cta dated (b)(6) 2024, prior to the re-intervention.Image set is incomplete and does not extend distal enough to review the entire aneurysm, aortic bifurcation, or iliac vessels.Images are arterial phase only.There appears to be wall apposition at the proximal end of the graft.There is a contrast-like density visible outside of the graft, however, contrast cannot be confirmed without a non-contrast or delay phase for comparison.Unable to confirm aneurysm growth with only one image set, and images are incomplete.Additional timepoints for comparison are not available for review.Max diameter visualized measures ~ 61 mm x 77 mm.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, endoleak and reoperation.

• 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: 19251822
• Report Number: 3007284313-2024-03208
• Device Sequence Number: 15102878
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/22/2024

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: 08/11/2019
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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; Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male