BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5611247 · Received April 27, 2016

    Report

    Report Number
    1649833-2016-70025
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    April 6, 2016
    Report Date
    July 25, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    DYE
    UDI-DI
    00851788001303
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2016, ON-X TECHNOLOGIES INCORPORATED (ON-X) BECAME A WHOLLY OWNED SUBSIDIARY OF CRYOLIFE, INC. (CRYOLIFE). IN MAY OF 2016, CRYOLIFE BECAME THE COMPLAINT HANDLER FOR ON-X COMPLAINTS. THE ACQUIRED ON-X COMPLAINT SYSTEM WAS REMEDIATED TO IDENTIFY ANY AREAS REQUIRING ACQUISITION OF ADDITIONAL INFORMATION FOR REGULATORY REPORTING. REMEDIATION OF THE OPEN COMPLAINT (B)(6) 2016 IDENTIFIED A NEED TO SUBMIT A FOLLOW-UP MDR TO INCLUDE THE RESULTS OF THE COMPLAINT INVESTIGATION. THE ESCAPED LEAFLET AND THE BROKEN LEAFLET, AS WELL AS THE VALVE HOUSING, FROM THE ONXMC-25/33 WAS RETURNED AND EVALUATED BY IN-HOUSE ENGINEERING AND A THIRD PARTY ENGINEERING FIRM WHO PERFORMED FRACTURE ANALYSIS. THE SUMMARY OF RESULTS INCLUDE THE FOLLOWING: THERE WAS NO INDICATION OF METAL TRANSFER FROM A SURGICAL INSTRUMENT ON THE LEAFLETS OR DAMAGE CAUSED TO THE HOUSING WHICH INDICATES THAT DAMAGE OCCURRED VIA THE ROTATOR. THE EVALUATION INDICATES "GIVEN THAT A PROPERLY SIZED ROTATOR WILL NOT ENGAGE THE LEAFLETS, THAT THIS OCCURRED DURING A ROTATION ATTEMPT AND THAT THERE IS NO METAL TRANSFER, IT IS MOST LIKELY THAT AN UNDERSIZED ROTATOR WAS USED. WHEN SUCH AN EVENT HAPPENS, THE ROTATOR WILL ENGAGE THE LEAFLETS AND IN THE MITRAL ORIENTATION WILL CAUSE THE LEAFLETS TO MOVE TOWARD CLOSURE, PINNING THE PROBE TIP OF THE ROTATOR BETWEEN THE LEAFLETS AND CAUSING AN OUTWARD FORCE ON THE LEAFLET PUTTING THE INFLOW SURFACE IN TENSION. THIS IS WHERE THE ORIGINATION OF THE THIS FRACTURE OCCURRED ALONG THE B DATUM BUT SLIGHTLY INBOARD AND ON THE INFLOW SURFACE." THE MANUFACTURING RECORDS FOR SN (B)(4) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD.

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE IS UNDERWAY, NOT YET COMPLETED. ONCE COMPLETED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DURING THE MITRAL VALVE REPLACEMENT PROCEDURE, AND AFTER VALVE SEWN INTO THE IMPLANTED POSITION, THE SURGEON ATTEMPTED TO USE THE ROTATOR TO TURN THE VALVE AND IN DOING SO, ONE LEAFLET ESCAPED AND THE OTHER BROKE. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME SIZE WITHOUT INCIDENT.

    Description of Event or Problem · 1

    DURING THE MITRAL VALVE REPLACEMENT PROCEDURE, AND AFTER VALVE SEWN INTO THE IMPLANTED POSITION, THE SURGEON ATTEMPTED TO USE THE ROTATOR TO TURN THE VALVE AND IN DOING SO, ONE LEAFLET ESCAPED AND THE OTHER LEAFLET BROKE. THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME SIZE WITHOUT INCIDENT. THIS IS BEING REPORTED AT THIS TIME BECAUSE THE INVESTIGATION IS NOT YET COMPLETE. ONCE THERE IS A CONCLUSION FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269010 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TECHNOLOGIES, INC ONXMC 00851788001303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention