BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 12160565 · Received July 13, 2021

    Report

    Report Number
    1718850-2021-01126
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 13, 2021
    Manufacturer
    CORCYM CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000429
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, A PERCEVAL VALVE PVS23 IMPLANT ATTEMPT OCCURRED. AFTER DECLAMPING OF THE AORTA, THE TRANSESOPHAGEAL ECHO (TEE) SHOWED A PERIVALVULAR LEAK (MILD) FROM THE RIGHT CORONARY CUSP (RCC). AFTER RE-CLAMPING AND CONFIRMING THE IMPLANT POSITION, A RCC ANNULUS PERFORATION WAS CONFIRMED. AFTER THE REPAIR USING A PATCH, ANOTHER PERCEVAL M WAS INDWELLED AND THE OPERATION WAS COMPLETED. THERE WAS NO PROBLEM WITH THE PERCEVAL PLACEMENT POSITION, AND IT SEEMS THAT THE PERFORATION OCCURRED WHEN THE ANNULUS WAS DECALCIFIED. EXTENDED TIME (CROSS-CLAMPING TIME: 46 MINUTES FOR THE FIRST TIME, 49 MINUTES FOR THE SECOND TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053889 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR CORCYM CANADA CORP. PVS23 00896208000429

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention