BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 8515311 · Received April 15, 2019

    Report

    Report Number
    2024168-2019-02927
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    January 1, 2013
    Report Date
    April 15, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT, IMPLANT DATE: ESTIMATED DATES. UDI #: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED. ENRICO AMMIRATI, ET AL, "SAFETY OF CENTRIFUGAL LEFT VENTRICULAR ASSIST DEVICE IN PATIENTS PREVIOUSLY TREATED WITH MITRACLIP SYSTEM." INTERNATIONAL JOURNAL OF CARDIOLOGY 283 (2019) 131-133. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND A DEFINITIVE CAUSE FOR THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) IN THIS INCIDENT COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE CLIP DETACHING FROM ONE LEAFLET AND REMAINING ATTACHED TO THE OTHER LEAFLET. IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT MITRACLIP MAY BE RELATED TO THE CLIP DETACHING FROM ONE LEAFLET AND REMAINING ATTACHED TO THE OTHER LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE TITLED "SAFETY OF CENTRIFUGAL LEFT VENTRICULAR ASSIST DEVICE IN PATIENTS PREVIOUSLY TREATED WITH MITRACLIP SYSTEM." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307939 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1