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

Catalog Number	PXC201000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The fsa reported the following to gore: on (b)(6) 2009, the patient underwent an endovascular procedure utilizing the gore® excluder® aaa endoprostheses (2 contralateral legs, 1 aortic extender, and 1 trunk-ipsilateral leg).On (b)(6) 2024, during a follow up ct scan, the physician contacted the fsa and reported that the patient had bilateral type 1b endoleaks.They plan to implant one ibe most likely on the left limb and then possibly one on the right as well in a few weeks.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include endoleaks.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
H.6: code b15 - images were provided, and an imaging evaluation was performed.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.The imaging evaluation determined the following: the post-implantation cta was dated (b)(6) 2024.There was contrast outside the implanted devices in the distal abdominal aorta aneurysm sac.Imaging showed the distal end of the contralateral leg on the patient¿s right-side ends in the abdominal aorta aneurysm.Thereby, there is lack of all apposition in the right common iliac (rci).The contralateral leg that extends from the ipsilateral leg into the left common iliac (lci) has also lost circumferential device apposition in the lci.Findings confirmed distal type 1 endoleaks, bilaterally.
Additional Manufacturer Narrative
Added g3/g4 and h1/h2 correction contact office - manufacturing site: from: (b)(6).To: (b)(6).

• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19688498
• Report Number: 3013164176-2024-02126
• Device Sequence Number: 20865815
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2024

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
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: PXC201000
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 09/03/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2009
• 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
• Patient Age: 81 YR
• Patient Sex: Male