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

Model Number	PXC181000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2011, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2016, a reintervention was performed to solve a type 1b endoleak of the gore® excluder® contralateral leg component plc181000 implanted into the patient¿s right common iliac artery.The underlying cause for the type 1b endoleak was reported to have been disease progression in the absence of device migration.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10073990
• Report Number: 2017233-2020-00374
• Device Sequence Number: 2835777
• Product Code: MIH
• UDI-Device Identifier: 00733132610006
• UDI-Public: 00733132610006
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 09/30/2013
• Device Model Number: PXC181000
• Device Catalogue Number: PXC181000
• Device Lot Number: 8410134
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 81