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

Model Number PXT261412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/15/2020

Event Type  Injury  

Event Description

Per (b)(6) - patient had a excluder implanted in 2017, the patient developed a common iliac artery aneurism which needed to be covered with another cardiac limb, and had to embolize the iliac arty and extend the limb in to the external iliac artery.

Manufacturer Narrative

H6: code 3331 replaced code 4118, as review of manufacturing paperwork was performed h6: code 213 the review of the manufacturing paperwork verified that this lot met all pre-release specifications; h6: code 22 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, aneurysm enlargementco.

Manufacturer Narrative

This event also includes device 06438929/ 00733132610037, 06620260/ 00733132609963 and 20059739/ 00733132609949.

Manufacturer Narrative

H10/11: previous medwatch identified one device as 0662429/ 00733132609949.The correct serial number is (b)(6).

Manufacturer Narrative

H10/11: device originally reported as 20059739/00733132609949 has an incorrectly reported lot number.The correct number is 0662429/00733132609949.

• Brand Name: GORE EXCLUDERAAA 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
• MDR Report Key: 10809260
• MDR Text Key: 215309655
• Report Number: 2017233-2020-01427
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610211
• UDI-Public: 00733132610211
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/25/2021

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: 02/29/2012
• Device Model Number: PXT261412
• Device Catalogue Number: PXT261412
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 10/15/2020; 10/15/2020; 10/15/2020
• Supplement Dates FDA Received: 11/17/2020; 12/05/2020; 03/23/2021; 03/25/2021
• Patient Sequence Number: 1
• Patient Age: 77 YR