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

Catalog Number	RMT281414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medications - aspirin, amlodipine, omeprazole, repatha.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to component migration, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2014, the patient underwent endovascular treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On an unknown date, a follow-up computed tomography scan identified a suspected proximal type i endoleak and aneurysm enlargement of an unknown amount.The cause of the proximal type i endoleak is reportedly due to distal migration (amount unknown) of the trunk-ipsilateral leg component.The migration was reported caused by dilatation of the aortic neck causing a loss of seal.On (b)(6) 2018, a reintervention was performed whereby an aortic extender component was implanted for proximal extension off of the trunk-ipsilateral leg component.It was reported the endoleak was resolved and the patient tolerated the procedure.

• 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: 8151632
• Report Number: 2017233-2018-00754
• Device Sequence Number: 2125538
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 11/30/2016
• Device Catalogue Number: RMT281414
• Device Lot Number: 12126842
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2018
• 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: 68 YR
• Patient Weight: 88