BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 8067360 · Received November 13, 2018

    Report

    Report Number
    3004478276-2018-00336
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 15, 2018
    Manufacturer
    LIVANOVA CANADA CORP
    Product Code
    LWR
    UDI-DI
    00896208000436
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PHYSICIAN'S JUDGEMENT, THE EVENT IS ATTRIBUTABLE TO THE PATIENT'S SPECIFIC ANATOMY AND NOT TO THE DEVICE. NO DEVICE PROBLEM IS SUSPECTED, AND NO FURTHER INVESTIGATION IS WARRANTED. DEVICE NOT AVAIABLE FOR RETURN.

    Description of Event or Problem · 0

    A PERCEVAL PVS25 WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY. IT WAS REPORTED THAT THE PATIENT'S ANNULUS WAS ODDLY SHAPED. THE PATIENT CAME OFF PUMP TWICE AND PARAVALVULAR LEAK WAS IDENTIFIED BOTH TIMES. THEREFORE, THE VALVE WAS EXPLANTED AND A EDWARDS MAGNA EASE 25 MM VALVE WAS IMPLANTED INSTEAD. THE PROCEDURE WAS DELAYED BY 1.5 HOURS AS A RESULT OF THE EVENT, AND THE PATIENT OUTCOME WAS GOOD. THE SURGEON REPORTED THAT THE EVENT WAS ATTRIBUTABLE TO THE PATIENT'S PARTICULAR ANATOMY AND NOT THE TO PERCEVAL VALVE.

    Additional Manufacturer Narrative · 1

    DISPOSITION NOT PRESENTLY KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERCEVAL VALVE WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903724 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP PVS25 00896208000436

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention