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

Catalog Number PLC271400

Device Problem Patient Device Interaction Problem (4001)

Event Date 03/03/2024

Event Type  Injury  

Manufacturer Narrative

H6: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak 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) 2017, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis main body and two limbs.The patient tolerated the procedure.On (b)(6) 2024, the patient presented with mid back pain.Imaging showed a descending aortic pau.The physician also noted a possible type ia endoleak on the main body, and type ib endoleaks on each of the limbs.While attempting to treat the pau, the physician tore the right external iliac artery.The physician used a gore® excluder® conformable aaa endoprosthesis with active control system to repair the pau.The physician then relined the existing grafts, which repaired the endoleaks and the torn reia.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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18980180
• MDR Text Key: 338620804
• Report Number: 2953161-2024-01207
• 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
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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 Expiration Date: 01/27/2020
• Device Catalogue Number: PLC271400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/26/2024
• Date Device Manufactured: 01/27/2017
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 85 KG