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

Catalog Number	RMT261216
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2013, the patient presented with an infra-renal abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.The patient tolerated the procedure and no endoleak was reported after the procedure.The patient was discharged on (b)(6) 2013.The pre-implant maximum aneurysm diameter was reported to be 52mm.On (b)(6) 2018, follow-up cat scan determined a type ia and a type ib endoleak on the left site along with significant aneurysm growth to 70mm.A previously seen and untreated type ii endoleak was not visible.A reintervention was performed on (b)(6) 2018.Two aortic extenders were implanted proximal at the edge of the left renal artery to treat the type ia endoleak.Additionally the right limb was extended with the implantation of a contralateral leg endoprosthesis to treat the type ib endoleak.The procedure was completed with favorable results.

• 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: 7994947
• Report Number: 2017233-2018-00636
• Device Sequence Number: 1381413
• Product Code: MIH
• UDI-Device Identifier: 00733132610600
• UDI-Public: 00733132610600
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 01/31/2016
• Device Catalogue Number: RMT261216
• Device Lot Number: 11110693
• 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: 10/23/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PXC271000/10506949.; PXC271000/10506949
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 105