BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10864517 · Received November 18, 2020

    Report

    Report Number
    2024168-2020-09689
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    September 1, 2014
    Report Date
    November 18, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A CAUSE FOR THE REPORTED HEART FAILURE, CARDIAC TAMPONADE, STROKE, TISSUE DAMAGE, HEMORRHAGE, ATRIAL FIBRILLATION, EMBOLISM, AND UNCHANGED MITRAL REGURGITATION COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF HEART FAILURE, CARDIAC TAMPONADE, CEREBROVASCULAR ACCIDENT, TISSUE DAMAGE, HEMORRHAGE, ATRIAL FIBRILLATION, EMBOLISM, AND UNCHANGED MITRAL REGURGITATION ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, AND ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED ADDITIONAL THERAPY/NON-SURGICAL TREATMENT WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ARTICLE TITLED, PERCUTANEOUS MITRAL VALVE EDGE-TO-EDGE REPAIR IN-HOSPITAL RESULTS AND 1-YEAR FOLLOW-UP OF 628 PATIENTS OF THE 2011¿2012 PILOT EUROPEAN SENTINEL REGISTRY.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT TO HEART FAILURE REQUIRING READMISSION, CARDIAC TAMPONADE, STROKE, VASCULAR DAMAGE [TISSUE DAMAGE], HEMORRHAGE REQUIRING TRANSFUSSION, ATRIAL FIBRILLATION, CLIP EMBOLIZATION, AND UNCHANGED MITRAL REGURGITATION. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP DEVICE WHICH MAYBE BE RELATED TO PATIENT HEART FAILURE REQUIRING READMISSION, CARDIAC TAMPONADE, STROKE, VASCULAR DAMAGE [TISSUE DAMAGE], HEMORRHAGE REQUIRING TRANSFUSSION, ATRIAL FIBRILLATION, CLIP EMBOLIZATION, AND UNCHANGED MITRAL REGURGITATION. DETAILS ARE LISTED IN THE ARTICLE, TITLED PERCUTANEOUS MITRAL VALVE EDGE-TO-EDGE REPAIR IN-HOSPITAL RESULTS AND 1-YEAR FOLLOW-UP OF 628 PATIENTS OF THE 2011¿2012 PILOT EUROPEAN SENTINEL REGISTRY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329534 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention| S