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

Model Number	PXC181000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on an unknown date in (b)(6) 2010, a patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis for an abdominal aortic aneurysm.On an unknown date, a follow up examination revealed a distal type i endoleak.It was reported, a likely cause of the endoleak was enlargement of left common iliac artery.On (b)(6) 2020, the patient underwent a reintervention.The left internal iliac artery was coil embolized and two additional stent grafts were deployed to extend the device to the left external iliac artery.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all 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: 10830762
• Report Number: 2017233-2020-01444
• Device Sequence Number: 4087311
• Product Code: MIH
• UDI-Device Identifier: 00733132610006
• UDI-Public: 00733132610006
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 08/31/2013
• Device Model Number: PXC181000
• Device Catalogue Number: PXC181000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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