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

Model Number	PXT261412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
This event also includes device 06438929/ 00733132610037, 06620260/ 00733132609963 and 20059739/ 00733132609949.
Additional Manufacturer Narrative
H10/11: previous medwatch identified one device as 0662429/ 00733132609949.The correct serial number is (b)(6).
Additional 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
• Common Device Name: 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
• Report Number: 2017233-2020-01427
• Device Sequence Number: 3798806
• Product Code: MIH
• UDI-Device Identifier: 00733132610211
• UDI-Public: 00733132610211
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2012
• Device Model Number: PXT261412
• Device Catalogue Number: PXT261412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020; 10/15/2020; 10/15/2020; 10/15/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/17/2020; 12/05/2020; 03/23/2021; 03/25/2021
• Patient Sequence Number: 1
• Patient Age: 77 YR