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

Catalog Number CXT281412E

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® conformable aaa endoprosthesis with active control system.During the procedure, the trunk ipsilateral leg migrated from the infrarenal neck and into the aneurysm.The physician converted the procedure to open surgery.The patient tolerated the procedure.

Manufacturer Narrative

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.

Manufacturer Narrative

An review of product history records showed: a review of the manufacturing records indicated the lots met pre-release specifications.An imaging evaluation showed: the main body of the device is deployed at the level of the renal arteries.On the final angio received, the device migrated from the initial position of deployment.A device evaluation showed: submitted unfixed was one gore excluder conformable aaa endoprosthesis with active control system.The lumens of the device were widely patent.The abluminal surface contained scattered dark red to brown staining (presumed blood).The area of the proximal trunk anchor row appeared to have a smaller diameter than the trunk body rows.The constraint sleeve was positioned alongside the contralateral gate.The trunk ipsilateral leg at the area of bifurcation was partially in-folded distal to the small taper row.Histopathological evaluation was not performed due to the lack of adherent tissue present on the device.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.No wear related disruptions were identified from the post-digestion evaluation.The ipsilateral leg at the area of bifurcation was still partially in-folded distal to the small taper row, but slightly less in-folded than examined in the gross evaluation.The device evaluation performed by engineering showed the following: there was no damage or abnormalities observed.No manufacturing deficiency could be identified.According to the gore® excluder® conformable aaa endoprosthesis with active control system instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to component migration.

Event Description

It was reported that on (b)(6) 2023, a patient presenting with an abdominal aortic aneurysm was treated with a gore® excluder® conformable aaa endoprosthesis with active control system.During the procedure, the trunk ipsilateral leg migrated from the infrarenal neck and into the aneurysm.The cause of the migration is unknown.An angiogram taken during final positioning of the trunk ipsilateral leg showed that it had landed below the lowest right renal artery.After the first step of deployment, the doctor tried to cannulate the contralateral leg.It was later observed that the trunk ipsilateral leg had migrated distally into the aneurysm.The physician converted the procedure to open surgery.The patient tolerated the procedure.

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18319653
• MDR Text Key: 330393423
• Report Number: 3007284313-2023-02944
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/17/2024

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: CXT281412E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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): Other