BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 9617776 · Received January 22, 2020

    Report

    Report Number
    2024168-2020-00830
    Event Type
    Death
    Date Received
    January 22, 2020
    Date of Event
    February 1, 2010
    Report Date
    July 24, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.NA - ATTACHMENT: [CN-020526.PDF]

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR MEDIAL AFFAIRS DIRECTOR. IN PAPER TITLED "EARLY AND MID-TERM OUTCOMES OF PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP: COMPARATIVE ANALYSIS OF DIFFERENT EUROSCORE STRATA¿, 85 PATIENTS WERE EVALUATED. OVERALL PROCEDURAL SUCCESS RATE WAS 96.5% WITH AN IN-HOSPITAL MORTALITY RATE OF 3.5%, WHICH IS WITHIN THE EXPECTED RANGE IN THIS HIGH-RISK ELDERLY POPULATION. FAILED PROCEDURES WERE REPORTED IN THREE PATIENTS DUE TO POST-PROCEDURAL SIGNIFICANT MITRAL VALVE STENOSIS, NEW MITRAL REGURGITATION (MR) GRADE 3 CAUSED BY PARTIAL DETACHMENT OF A CLIP TWO WEEKS AFTER THE INITIAL SUCCESSFUL PROCEDURE, AND NEW SIGNIFICANT MR DUE TO COMPLETE CLIP DETACHMENT AND EMBOLISM. INDIVIDUAL PATIENT INFORMATION IS NOT AVAILABLE TO ANALYZE BASELINE CHARACTERISTICS AND PROCEDURAL INFORMATION, BUT THE REPORTED COMPLICATION RATE REMAINS LOW AND WITHIN ACCEPTABLE RANGE. H10 - MEDICAL REVIEW ADDED.

    Additional Manufacturer Narrative · 0

    D4: UDI NUMBER IS UNKNOWN AS THE PART AND LOT NUMBER WAS NOT PROVIDED. 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 DEVICES WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF DEATH AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. PATIENT EFFECTS OF DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE IS A KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND/OR DEVICE ISSUES REFERENCED IN THE ARTICLE LISTED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ARTICLE TITLED "EARLY AND MID-TERM OUTCOMES OF PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP: COMPARATIVE ANALYSIS OF DIFFERENT EUROSCORE STRATA¿.

    Description of Event or Problem · 1

    THIS IS BEING FILED TO REPORT DEATH. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING MITRACLIP AND STEERABLE GUIDE CATHETER DEVICES AND THAT MAY BE RELATED TO THE FOLLOWING: SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, COMPLETE CLIP DETACHMENT, RECURRENT MITRAL REGURGITATION (MR), WORSENING MR, MYOCARDIAL INFARCTION, FOREIGN BODY, EMBOLIZATION, ISCHEMIA, STROKE, HEMORRHAGE, HEART FAILURE, STROKE, RENAL FAILURE, ATRIAL PERFORATION, MEDICAL INTERVENTION, SURGICAL INTERVENTION, PROLONGED HOSPITALIZATION, AND DEATH. DETAILS ARE LISTED IN THE ARTICLE, TITLED "EARLY AND MID-TERM OUTCOMES OF PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP: COMPARATIVE ANALYSIS OF DIFFERENT EUROSCORE STRATA¿. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78638 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death