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

Model Number	PXT231214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.No issues were observed during the procedure.On an unknown date, follow-up exam identified aneurysm enlargement (amount unknown).The cause of the enlargement was reportedly a suspected proximal type i endoleak, distal type i endoleak from the right leg (ipsilateral side), or type ii endoleak originating from lumber arteries.On (b)(6) 2021, additional stent grafts were implanted to extend the proximal neck and right leg.Coil embolization was also performed to the lumber arteries.The patient tolerated the procedure.
Additional Manufacturer Narrative
Revised g1.

• Brand Name: GORE EXCLUDER AAA 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: 11592834
• Report Number: 2017233-2021-01831
• Device Sequence Number: 11953824
• Product Code: MIH
• UDI-Device Identifier: 00733132610105
• UDI-Public: 00733132610105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 12/31/2013
• Device Model Number: PXT231214
• Device Catalogue Number: PXT231214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR