BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERTAS PLUS VALVE

    MDR report key: 10280269 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00217
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    April 15, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D10, G4, G7, H2, H3, H4, H6, H10. UDI : (B)(4). DHR - LOT 4081212, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK . FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS INSIDE THE VALVE, AND NEEDLE HOLES IN THE NEEDLE CHAMBER. THE VALVE FAILED THE TEST FOR PROGRAMMING AND REFLUX. THE VALVE WAS LEAK TESTED, LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER, COULD NOT BE PRESSURE TESTED DUE TO PROGRAMMING ISSUE. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS NOTED ON THE ROTATING CONSTRUCT, ON THE HELICAL SPRING, ON THE CAM/BALL ARM ASSEMBLY, ON THE RUBY BALL, AND ON THE SEAT OF RUBY BALL. THE VALVE PASSED THE FLUSH TEST. THE ROOT CAUSE FOR THE PROGRAMING ISSUE NOTED DURING THE INVESTIGATION IS DUE TO BIOLOGICAL ON THE ROTATION CONSTRUCT. THE POSSIBLE ROOT CAUSE FOR THE OCCLUSION REPORTED BY THE CUSTOMER WAS PROBABLY DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP. ADDITIONAL INFORMATION RECEIVED: THE ISSUE WAS AFTER IMPLANTATION.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE CERTAS VALVE BECAME OBSTRUCTED AND REVISION SURGERY WAS NECESSARY. THE EVENT LED TO 2 HOURS SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739808 UNKNOWN CERTAS PLUS VALVE CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1