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

Catalog Number CXT201412

Device Problems Difficult to Fold, Unfold or Collapse (1254); Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: code b20: device remains implanted and therefore not available for direct analysis.H.6.: code d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to endoleaks, aneurysm expansion and reoperation.Adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: conversion.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: improper component placement; incomplete component deployment; 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 an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.A stent graft (cuff) was previously placed within the aneurysm for an embolization of the inferior mesenteric artery.A trunk ipsilateral leg endoprosthesis was subsequently deployed.The contralateral gate was deployed in an anterior/ventral direction, and an entrance of the gate was compressed due to the lack of space in the aneurysm.As contralateral gate cannulation became difficult, the procedure was changed to aui and a femoral-femoral artery bypass surgery was performed.The patient was reported to have had a saccular type aortic aneurysm protruding towards the dorsal.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18414687
• MDR Text Key: 331581728
• Report Number: 3007284313-2023-02982
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/28/2023

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: CXT201412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• 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; Other
• Patient Age: 74 YR
• Patient Sex: Female