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

Model Number	PXC141200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/19/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted the gore® excluder® aaa endoprosthesis instructions for use states ¿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) 2012, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, a distal type i endoleak in the right leg was reportedly observed.The cause of the endoleak was not reported.On (b)(6) 2014, a reintervention was performed whereby an additional stent graft was implanted to extend distally on the right side.The patient tolerated the procedure.

• 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: 12005435
• Report Number: 3007284313-2021-01472
• Device Sequence Number: 11921330
• Product Code: MIH
• UDI-Device Identifier: 00733132609956
• UDI-Public: 00733132609956
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 05/31/2015
• Device Model Number: PXC141200
• Device Catalogue Number: PXC141200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR