BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3216712 · Received July 3, 2013

    Report

    Report Number
    3008011247-2013-00017
    Event Type
    Death
    Date Received
    July 3, 2013
    Date of Event
    January 14, 2013
    Report Date
    June 12, 2013
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SUCCESSFUL ENDOVASCULAR REPAIR OF AAA USING THE TRIVASCULAR OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2012 AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 FOLLOWING A REVIEW OF THE POST-OPERATIVE IMAGING OBTAINED ON (B)(6) 2012. ACCORDING TO THE POST-OPERATIVE IMAGING REVIEW BY THE IMPLANTING PHYSICIAN PRIOR TO PT DISCHARGE, THE ENDOVASCULAR REPAIR OF THE PT'S AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM WAS SUCCESSFULLY COMPLETED ON (B)(6) 2013, WITH NO ADVERSE PT SEQUELAE. THE PT DID NOT RETURN FOR THE 1-MONTH OR 6-MONTH ROUTINE F/U VISITS. ON (B)(6) 2013, THE IMPLANTING PHYSICIAN WAS NOTIFIED BY THE PT'S PRIMARY CARE PHYSICIAN THAT THE PT HAD BEEN FOUND DEAD IN HIS HOME ON (B)(6), 2013 OF UNK CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305975 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2980-D FS061212-11

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other