BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6690741 · Received July 6, 2017

    Report

    Report Number
    2024168-2017-05670
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    June 13, 2017
    Report Date
    August 22, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - 324107/1-2. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND ALTHOUGH ABBOTT VASCULAR (AV) COULD NOT CONFIRM THE REPORTED BENDING SHAFT, THE REPORTED INABILITY TO TURN THE M KNOB WAS CONFIRMED. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO SIMILAR INCIDENTS FROM THIS LOT. FURTHER INVESTIGATION WAS PERFORMED AND AV DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE ABSENCE OF THE OIL LUBRICANT ON THE BRAKE SHAFT. AV DETERMINED THAT THIS IS AN ISOLATED INCIDENT AND THERE IS NO INDICATION THAT THIS ISSUE IMPACTS A WIDER POPULATION OF PRODUCT. AV WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE DIFFICULTY POSITIONING THE DEVICE. IT WAS REPORTED THAT DURING A MITRACLIP PROCEDURE TO TREAT GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), WHILE POSITIONING THE CLIP DELIVERY SYSTEM (CDS) ABOVE THE MITRAL VALVE, TENSION AND A BEND WERE NOTED. ADDITIONALLY, THE M KNOB WAS UNABLE TO BE TURNED AND THE TRAJECTORY OF THE DEVICE WAS NOT GOOD. THE CDS WAS REMOVED AND REPLACED. ONE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO GRADE 1. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470075 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60622U217

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR