BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 9847514 · Received March 18, 2020

    Report

    Report Number
    2024168-2020-02577
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    December 1, 2009
    Report Date
    July 28, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [CN-024346.PDF].

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF HEART FAILURE, SURGICAL PROCEDURE, UNCHANGED MITRAL REGURGITATION, HEMORRHAGE, PROLONGED HOSPITALIZATION, ADDITIONAL NON-SURGICAL TREATMENT (INTRA-AORTIC-BALLOON PUMP), RECURRENT MITRAL REGURGITATION, TREATMENT WITH MEDICATIONS AND ADDITIONAL NON-SURGICAL TREATMENT, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED HEART FAILURE UNCHANGED MITRAL REGURGITATION, HEMORRHAGE, AND RECURRENT MITRAL REGURGITATION CANNOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI NUMBER IS UNKNOWN AS PART AND LOT NUMBERS WERE NOT REPORTED. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH AND THE DEVICE ISSUE OF SINGLE LEAFLET DEVICE ATTACHMENT/SLDA ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORTS. LITERATURE ARTICLE TITLED, "LEFT VENTRICULAR REVERSE REMODELLING PREDICTS LONG-TERM OUTCOMES IN PATIENTS WITH FUNCTIONAL MITRAL REGURGITATION UNDERGOING MITRACLIP THERAPY: RESULTS FROM A MULTICENTRE REGISTRY.¿

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT RECURRENT MITRAL REGURGITATION (MR), UNCHANGED MR, HEMORRHAGE, HEART FAILURE, MEDICAL INTERVENTION, SURGICAL INTERVENTION, AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING MITRACLIP DEVICES THAT MAY BE RELATED TO THE FOLLOWING: SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, RECURRENT MITRAL REGURGITATION (MR), UNCHANGED MR, HEMORRHAGE, HEART FAILURE, MEDICAL INTERVENTION, SURGICAL INTERVENTION, PROLONGED HOSPITALIZATION, AND DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "LEFT VENTRICULAR REVERSE REMODELLING PREDICTS LONG-TERM OUTCOMES IN PATIENTS WITH FUNCTIONAL MITRAL REGURGITATION UNDERGOING MITRACLIP THERAPY: RESULTS FROM A MULTICENTRE REGISTRY." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310584 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S