BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 11422895 · Received March 5, 2021

    Report

    Report Number
    2024168-2021-01741
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    September 1, 2012
    Report Date
    March 5, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY FOR THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE, FOREIGN BODY IN PATIENT, HEMORRHAGE, ARRHYTHMIA, THROMBOSIS, AND PERICARDIAL EFFUSION ARE DUE TO PROCEDURAL CIRCUMSTANCE/ OPERATIONAL CONTEXT. THE REPORTED PATIENT EFFECTS OF TISSUE DAMAGE, FOREIGN BODY IN PATIENT, HEMORRHAGE, ARRHYTHMIA, THROMBOSIS, AND PERICARDIAL EFFUSION AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. ADDITIONALLY, SURGICAL PROCEDURE, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND HOSPITALIZATION ARE A RESULT OF CASE SPECIFIC CIRCUMSTANCES AS DOCUMENTED WITHIN THE RESEARCH ARTICLE. THERE IS NO INDICATION OF PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE ¿INITIAL FRENCH EXPERIENCE OF PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP: A MULTICENTRE NATIONAL REGISTRY¿NA

    Description of Event or Problem · 1

    THIS IS BEING FILED TO REPORT THE ADVERSE PATIENT EFFECTS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING MITRACLIP THAT MAY BE RELATED TO SURGICAL INTERVENTION, HOSPITALIZATION, TISSUE DAMAGE, FOREIGN BODY, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, DEEP VENOUS THROMBOSIS, BLEEDING AT PUNCTURE SITE, ATRIAL ARRHYTHMIA, ACUTE FEBRILE RESPIRATORY ILLNESS, TAMPONADE TREATED BY PERCUTANEOUS DRAINAGE. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE: INITIAL FRENCH EXPERIENCE OF PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP: A MULTICENTRE NATIONAL REGISTRY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322714 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R