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

Catalog Number CXT361414

Device Problem Positioning Failure (1158)

Patient Problem Rupture (2208)

Event Date 03/22/2024

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2024, the patient presented with a ruptured aneurysm and a proximal type i endoeleak.And a ruptured aneurysm and underwent reinvention.The previous grafts were all relined with a gore® excluder® conformable aaa endoprosthesis and two gore® excluder® contralateral leg components.The patient tolerated the procedure and the endoleak was resolved.It was reported that degeneration of the patient¿s proximal neck had caused the diameter of the aortic neck to enlarge, and it was bigger than the diameter of the device originally implanted.Migration of the device (distance unknown) led to the type i-a endoleak and the rupture.

Manufacturer Narrative

B7: patient medical history includes but is not limited to: chronic kidney disease, hypertension, hyperlipidemia, atrial flutter, stroke.D10: patient medications include but is not limited to: albuterol, calcitriol, cetrizine, empagliflozin, lisinopril, lorazepam, simvastatin.The instructions for use (ifu) for the gore® excluder® conformable aaa endoprosthesis states, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak, aneurysm rupture, migration.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.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Type of Device: 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19058333
• MDR Text Key: 339562145
• Report Number: 3007284313-2024-03159
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: 00733132651078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2024

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 Operator: Health Professional
• Device Catalogue Number: CXT361414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG