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

Catalog Number	PLC181200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include endoleak.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 information was reported to gore: on (b)(6) 2024, the patient had an endovascular procedure to treat an aortoiliac aneurysm with a possible type 1 b endoleak on a previously implanted gore® excluder® aaa endoprosthesis (contra leg).The contra leg was implanted in 2022 and there are no ct images to confirm the endoleak.A gore® excluder® iliac branch endoprosthesis (ibe) was implanted without issue.In addition, a 11 mm x 79 mm gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent graft) was intended for use in the right hypogastric artery as an extension of the ibe.It was reported that access was gained through the left brachial artery and a 0.035¿ cordis storq steerable guidewire was used.Reportedly, there was difficulty with advancement of vbx stent graft delivery catheter through a upsized 9 f cook introducer sheath, the contra leg, the ibe, and the patient¿s tortuous anatomy.Consequently, the physician decided to remove the vbx stent graft delivery catheter prior to deployment to possibly use a 11 mm x 59 mm instead to have better trackability.It was noted, that when the physician pulled back on the vbx stent graft delivery catheter hub with normal force the catheter shaft broke where it connects to the hub (outside the patient).The physician then ran fluoroscopy and the vbx stent graft appeared to be dislodged from the balloon prematurely.The undeployed vbx stent graft was snared and the removed entirely without any further complications.The physician also suspected that the introducer sheath may have kinked during the procedure.The procedure was successfully completed by coiling the right hypogastric artery.The contra leg and ibe remain implanted.There were no consequences to the patient related to this event.

• 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 SILICON VALLEY; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19619587
• Report Number: 3007284313-2024-03332
• Device Sequence Number: 17881182
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/26/2024

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: 05/23/2024
• Device Catalogue Number: PLC181200
• 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: 05/29/2024
• Initial Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 02/15/2022
• 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: 76 YR
• Patient Sex: Male