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

Catalog Number	RLT231416
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event or Problem Description
The following information was reported to gore: on an unknown date, this patient was treated during an open surgery with a bifurcated prosthesis for an abdominal aortic aneurysm.On (b)(6) 2018, the patient underwent an endovascular procedure with gore® excluder® endoprostheses to treat a pseudoaneurysm of the right common iliac artery which had developed at the anastomosis connecting the vessel and the right limb of the previously implanted graft.For this reason, a trunk-ipsilateral leg component rlt231416 was advanced through the existing graft to be deployed at the intended location.However, having performed initial deployment of the rlt component, it was realized that the aortic neck length had been misjudged.The endoprosthesis had been placed too low and it was therefore not possible to cannulate the contralateral gate.As the position could not be corrected, it was decided to fully deploy the ipselateral leg which nevertheless excluded the pseudoaneurysm in the right common iliac artery.To ensure distal blood supply on the left patient side, the common iliac artery was plugged and the patient received a femoro-femoral crossover bypass from right to left.A conversion to open surgery did not take place.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: 7797703
• Report Number: 3007284313-2018-00236
• Device Sequence Number: 2076165
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 04/19/2021
• Device Catalogue Number: RLT231416
• Device Lot Number: 18036551
• 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: 08/20/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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