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

Catalog Number	PLA360400
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to 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 field sales associate (fsa) reported the following: on (b)(6) 2024, the patient was implanted with gore® excluder® conformable aaa endoprostheses to treat a ruptured abdominal aortic aneurysm.It was reported that the patient was admitted emergently with a ruptured abdominal aortic aneurysm.The patient had an extremely angulated aortic neck.While deploying the trunk-ipsilateral leg endoprosthesis the device migrated approximately 5mm below the left renal artery (lowest renal artery).This resulted in a proximal type i endoleak.The physician implanted a conformable aortic extender endoprosthesis to treat the endoleak.The device also migrated distally into the proximal portion inside the neck of the trunk-ipsilateral leg endoprosthesis.The proximal type i endoleak remained.The physician implanted a second aortic extender endoprosthesis and ballooned.There was a slight blushing during the final angiogram, the proximal type i endoleak remained.Reportedly, the final angiography images were poor quality due to the patient¿s obesity.Both a proximal type i and a distal type i endoleak remained.One unit of blood was given during the procedure due to the ruptured aneurysm upon patient¿s hospital arrival.On (b)(6) 2024, there was a reintervention to repair the unresolved endoleak from the procedure on (b)(6) 2024.The physician planned a physician modified endograft (pmeg) procedure.A gore® excluder® conformable aaa endoprosthesis (cxt321414/28256561) was modified for the procedure.There were portals made to the graft for the renal arteries.Two fenestrations were created, one for the superior mesenteric artery and one for the celiac artery.The gore® excluder® conformable aaa endoprosthesis was implanted proximal to the celiac artery.The physician was unable to cannulate the celiac artery, the bare fenestration still allowed profusion to the celiac artery.The endoleak was resolved.The patient tolerated the reintervention 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19374093
• Report Number: 3013164176-2024-02076
• Device Sequence Number: 7688786
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 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: 10/19/2025
• Device Catalogue Number: PLA360400
• 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: 04/30/2024
• Initial Report FDA Received Date: 05/22/2024
• Date Device Manufactured: 10/21/2022
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 147 KG