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

Catalog Number PLC161400J

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

H.6.: investigation findings: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: type of investigation: code b20: device remains implanted and therefore not available for direct analysis.H.6.: investigation conclusions: code d12:   according to the gore® excluder® aaa endoprosthesis instructions for use, (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, device/native vessel obstruction and, or occlusion.H.6.: investigation conclusions: code d1103: according to the gore® excluder® aaa endoprosthesis instructions for use, (ifu), implant procedure states : do not attempt to reposition the endoprosthesis after complete deployment of the device.Vessel damage or device misplacement may result.Additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Per ifu, additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.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 was reported to gore: on (b)(6) 2024, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral leg) and gore® excluder® aaa endoprostheses.When a contralateral leg endoprosthesis (b)(4) was deployed in the left common iliac artery, the contralateral leg covered the ostium of the left internal iliac artery.The blood flow of the left internal iliac artery was delay but it was still secured.The contralateral leg was pushed up using a gore® molding & occlusion balloon catheter.However, it seemed that the contralateral leg was pushed up slightly but almost not changed.A bare metal stent was implanted in the left internal iliac artery.Digital subtraction angiography (dsa) revealed the blood flow of the internal iliac artery improved.The patient tolerated the procedure.The physician stated that the contralateral leg was deployed with pushing up technique but the force for pushing up the contralateral leg was not enough.

Manufacturer Narrative

H.6.Investigation conclusions: code d1103 updated to code d1101.

• Brand Name: GORE® EXCLUDER® 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19083841
• MDR Text Key: 339875870
• Report Number: 3013164176-2024-02036
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• 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: 04/23/2024

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: PLC161400J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2024
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female