BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 6434343 · Received March 24, 2017

    Report

    Report Number
    3004478276-2017-00042
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 1, 2017
    Report Date
    March 24, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Removal / Correction Number
    Z-0716-2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FROM AN ARTICLE TITLED "THE RISK OF OVERSIZING WITH SUTURELESS BIOPROSTHESIS IN SMALL AORTIC ANNULUS," IT WAS REPORTED THAT DURING AVR WITH A PERCEVAL M +TV ANNULOPLASTY PERFORMED IN FULL STERNOTOMY, THE VALVE SIZE M WAS CURRENTLY DEPLOYED AND POSITIONED, BUT THE STENT KINKED AT THE LEVEL OF THE NONCORONARY SINUS AFTER THE AORTA WAS CLOSED. DURING POST-IMPLANT (INTRA-OP) TEE PARAVALVULAR LEAK WAS DETECTED. THE VALVE WAS REPLACED WITH A PERCEVAL SIZE S. THE OUTCOME OF THE PATIENT WAS GOOD WITH GOOD FUNCTIONALITY OF THE VALVE. THE PATIENT'S AORTIC CROSS CLAMP TIME WAS 112 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214075 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. PVS23

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention