MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT281418
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 aneurysm enlargement, endoleak and component migration.
Event or Problem Description
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2016 a patient underwent treatment of an abdominal aortic aneurysm and a left internal iliac aneurysm with gore® excluder® aaa endoprostheses.The maximum aortic diameter was 58.6mm.On (b)(6) 2016 the maximum aortic diameter by ct was 65mm.On (b)(6) 2019 the maximum aortic diameter by cta was 55mm.A type 1b endoleak was discovered in the right common iliac artery.Proximal migration of the graft limb into the aortic sac was also reported.On (b)(6) 2020 a reintervention took place with extension of the endoprosthesis.On (b)(6) 2020 the type 1b endoleak was deemed as resolved.
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: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9885461
• Report Number: 3007284313-2020-00077
• Device Sequence Number: 16826374
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2018
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Device Lot Number: 14048651
• 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: 03/26/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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: 73 YR
• Patient Weight: 153