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

Catalog Number PLC271400

Device Problem Positioning Failure (1158)

Patient Problem Aneurysm (1708)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

B7: patient medical history includes but is not limited to: hypertension.Ok.Diabetic.Right, cerebral vascular disease with tia, smoker, coronary artery disease, dyslipidemia, parkinson's.D10: patient medications include but are not limited to: eliquis, toporal, nizoral, glucophage, prinovil, lasix, zinc, vitamin c & d, remeron, sinemett, h6: code 22: the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states; adverse events that may occur and / or require intervention include but are not limited to: aneurysm enlargement.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

On (b)(6), 2019, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6), 2023, the patient underwent reintervention for a lack of circumferential apposition of the right common iliac limb (plc271400/ 18460808).It was reported that seal had been lost as the right common iliac artery had become aneurysmal causing dilation of the artery.The physician went in and extended the limb down to the external iliac artery, with intentional coverage of the internal iliac artery which was occluded.No endoleak was seen, just the iliac artery aneurysm that had developed had caused the limb to lose apposition.The patient tolerated the procedure.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18062339
• MDR Text Key: 327245323
• Report Number: 3013164176-2023-01885
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: 00733132618606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2023

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 Expiration Date: 08/10/2021
• Device Catalogue Number: PLC271400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Date Device Manufactured: 08/11/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 103 KG