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

Catalog Number CXT261412

Device Problems Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® excluder® conformable aaa endoprosthesis for use (ifu), 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 Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date after the initial procedure, during follow-up, a proximal type i endoleak and a type iiia endoleak from the contralateral gate of the trunk - ipsilateral leg endoprosthesis were suspected.On (b)(6) 2024, a reintervention was performed.No clear endoleak was identified by angiography, but ct and ultrasonography showed endoleak, so additional stent grafts were implanted in the proximal side of the trunk - ipsilateral leg endoprosthesis and in the overlap part of the contralateral gate as planned.In addition, a type ii endoleak was also suspected, so the inferior mesenteric artery was coil embolised.The patient tolerated the procedure.Reportedly, the proximal neck was angulated and severe calcification was observed from preoperatively.

• 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: mami nagashima ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18984888
• MDR Text Key: 338660311
• Report Number: 3007284313-2024-03137
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: 00733132651030
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

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: CXT261412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male