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

Catalog Number CXT321414

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

On (b)(6)2024, the patient underwent emergent endovascular treatment of a ruptured infrarenal abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.It was reported that the trunk-ipsilateral leg component was advanced and the first deployment step was completed with no issues.As the physician attempted to constrain the device to pull it down, it was reported that the proximal end of the device appeared to be irregular and did not appear to constrain uniformly.When the device was reopened it reportedly appeared that one side was pulled down approximately 1 cm lower than the other side which caused the graft to sit without circumferential device apposition.It was reported that there was device seal and no endoleak was present at the close of the procedure.There was no patient sequalae and the procedure was completed.There were no further reported issues.The patient tolerated the procedure.

Manufacturer Narrative

A.4.Patient weight: asked but unavailable b.7.Other relevant history, including preexisting medical conditions: asked but unavailable d.10.Concomitant medical products and therapy dates: asked but unavailable h.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.H.6.Type of investigation: code b15 - as the device remains implanted, an evaluation of the physical device is unable to be performed.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19033836
• MDR Text Key: 339263940
• Report Number: 3007284313-2024-03154
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651061
• UDI-Public: 00733132651061
• 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,Followup
• Report Date: 05/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXT321414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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 Age: 75 YR
• Patient Sex: Male