BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10351165 · Received July 31, 2020

    Report

    Report Number
    2024168-2020-06367
    Event Type
    Injury
    Date Received
    July 31, 2020
    Date of Event
    May 31, 2020
    Report Date
    July 31, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATES ARE 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 REGARDING THE COMPLAINT DEVICES WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED A CONCLUSIVE CAUSE FOR THE REPORTED ANAPHYLACTIC SHOCK, RESPIRATORY FAILURE, HEMORRHAGE, RECURRENT MITRAL REGURGITATION, HEART FAILURE, AND RENAL FAILURE CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF ANAPHYLACTIC SHOCK, RESPIRATORY FAILURE, HEMORRHAGE, RECURRENT MITRAL REGURGITATION, HEART FAILURE, AND RENAL FAILURE, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ATTACHMENT: ARTICLE TITLED, OUTCOMES OF URGENT/EMERGENT TRANSCATHETER MITRAL VALVE REPAIR (MITRACLIP): A SINGLE CENTER EXPERIENCE.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT SHOCK, RESPIRATORY FAILURE, BLEEDING, RECURRENT MITRAL REGURGITATION (MR), HEART FAILURE AND KIDNEY FAILURE. IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT FROM JANUARY 2018 TO MARCH 2019, 20 PATIENT PATIENTS UNDERWENT URGENT/EMERGENT TRANSCATHETER MITRAL VALVE REPAIR WITH A MITRACLIP. OVER THE 14-MONTH PERIOD, THE MITRACLIP MAY HAVE CONTRIBUTED TO SHOCK, RESPIRATORY FAILURE, BLEEDING, RECURRENT MITRAL REGURGITATION (MR), HEART FAILURE, KIDNEY FAILURE, HOSPITALIZATION, MEDICAL INTERVENTION AND SURGICAL INTERVENTION. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿OUTCOMES OF URGENT/EMERGENT TRANSCATHETER MITRAL VALVE REPAIR (MITRACLIP): A SINGLE CENTER EXPERIENCE.¿ NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815662 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R| S