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	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); No Code Available (3191)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for analysis.(b)(4).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 endoleak and aneurysm enlargement.As the date of the distal type i endoleak and the aneurysm enlargement is unknown, (b)(6) 2020 - the date of the re-intervention will be used as an event date.
Event or Problem Description
On (b)(6) 2012, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, it was observed a distal type i endoleak and an aneurysm enlargement.On (b)(6) 2020, a re-intervention was performed.A contralateral leg component was placed to treat the distal type i endoleak.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: 10900460
• Report Number: 2017233-2020-01488
• Device Sequence Number: 2542787
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 09/30/2014
• Device Model Number: PXC181000
• Device Catalogue Number: PXC181000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: 89 YR