BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10352859 · Received July 31, 2020

    Report

    Report Number
    2024168-2020-06388
    Event Type
    Death
    Date Received
    July 31, 2020
    Date of Event
    January 1, 2017
    Report Date
    August 28, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE COMPLAINT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH - ESTIMATED. DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THE CLIP REMAINS IN PATIENTS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. ARTICLE TITLED: ¿TEMPORAL TRENDS AND OUTCOMES FOLLOWING URGENT/EMERGENT TRANSCATHETER MITRAL VALVE REPAIR IN THE UNITED STATES.¿ THE OTHER PATIENT EFFECTS REFERENCED IN THE ARTICLE ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. [(B)(4)].

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE PATIENT DEATHS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP DEVICE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATHS, STROKE, ACUTE KIDNEY INJURY, HEMODIALYSIS, BLEEDING, BLOOD TRANSFUSION, INFECTIVE ENDOCARDITIS, CARDIAC TAMPONADE, CARDIAC ARREST, CARDIOGENIC SHOCK, HEART FAILURE, MITRAL VALVE SURGERY, MEDICATION, MEDICAL INTERVENTION, AND HOSPITALIZATION. DETAILS ARE LISTED IN THE ARTICLE, TITLED ¿TEMPORAL TRENDS AND OUTCOMES FOLLOWING URGENT/EMERGENT TRANSCATHETER MITRAL VALVE REPAIR IN THE UNITED STATES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813592 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death