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

Model Number	PXC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as it is not known which device was involved in the distal type i endoleak, the following device is also being investigated: pxc141400sn 11180177 udi: 00733132609963.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleaks.
Event or Problem Description
On (b)(6) 2013, a patient underwent endovascular treatment of abdominal aortic aneurysms using gore® excluder® aaa endoprostheses.On an unknown date, enlargement of the aneurysm diameter (amount unknown) and a distal type i endoleak from the left leg were noted.The device implanted on left distal side was either pxc141400/11180177 or pxc141400/11180180, not determined by the reporter.It was also confirmed that there was lack of apposition of pxa280300/10067062 at the inner curvature of the proximal aortic neck.On (b)(6) 2020, re-intervention was performed.The left internal iliac artery was coil embolized and an additional stent graft was implanted in the left external iliac artery.The distal type i endoleak was no longer detectable.During the operation, a proximal type i endoleak was not identified, however an additional stent graft was implanted in the proximal neck to solve the lack of apposition.The physician commented that the proximal neck of the patient was angled, so the lack of apposition in the proximal side was considered to be due to the patient¿s anatomy.
Additional Manufacturer Narrative
H.6.Results code 1:213: a review of the manufacturing records for the device verified the lot met pre-release specifications.

• 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: 10385542
• Report Number: 2953161-2020-01004
• Device Sequence Number: 2898479
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 01/31/2016
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 84 YR