BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10022487 · Received May 4, 2020

    Report

    Report Number
    2024168-2020-04090
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    September 1, 2017
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ARTICLE ATTACHMENT: ¿THE FIRST 4 YEARS OF POSTMARKETING SAFETY SURVEILLANCE RELATED TO THE MITRACLIP DEVICE: A UNITED STATES FOOD AND DRUG ADMINISTRATION MAUDE EXPERIENCE."NA - ATTACHMENT: [ARTICLE CN 030754.PDF].

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IMPLANT DATE - ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION WAS NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED COMPLETE CLIP DETACHMENT, CLIP CAUGHT IN CHORDAE, INABILITY TO GRASP, AND SINGLE LEAFLET DEVICE ATTACHMENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE DEATHS AND OTHER ADVERSE EVENTS MENTIONED ARE FILED UNDER SEPARATE MFR NUMBERS. ATTACHED LITERATURE TITLE : THE FIRST 4 YEARS OF POSTMARKETING SAFETY SURVEILLANCE RELATED TO THE MITRACLIP DEVICE: A UNITED STATES FOOD AND DRUG ADMINISTRATION MAUDE EXPERIENCE.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, CLIP ENTANGLEMENT, AND COMPLETE CLIP DETACHMENT. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP DEVICE THAT MAY BE RELATED TO THE FOLLOWING ADVERSE EVENTS: PATIENT DEATHS, TISSUE DAMAGE, MITRAL STENOSIS, STROKE, MYOCARDIAL INFARCTION, HOSPITALIZATION, MEDICAL INTERVENTION, AND SURGICAL INTERVENTION, AND THE FOLLOWING DEVICE ISSUES: UNABLE TO GRASP THE LEAFLETS, SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, CLIP ENTANGLEMENT, AND COMPLETE CLIP DETACHMENT. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿THE FIRST 4 YEARS OF POSTMARKETING SAFETY SURVEILLANCE RELATED TO THE MITRACLIP DEVICE: A UNITED STATES FOOD AND DRUG ADMINISTRATION MAUDE EXPERIENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484052 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1