BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15212205 · Received August 11, 2022

    Report

    Report Number
    2135147-2022-00724
    Event Type
    Death
    Date Received
    August 11, 2022
    Date of Event
    April 16, 2022
    Report Date
    October 10, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIPS REMAIN IN PATIENTS. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE REPORTED SERIOUS INJURIES AND MALFUNCTION REFERENCED ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. DATE OF DEATH: ESTIMATED (B)(6) 2022. DATE OF EVENT: ESTIMATED (B)(6) 2022. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PARTS AND LOT NUMBERS WERE NOT PROVIDED. IMPLANT DATE: ESTIMATED (B)(6) 2022. LITERATURE: "MITRAL VALVE SURGERY AFTER FAILED MITRACLIP-OPERATION FOR THE INOPERABLE?"

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A LOT HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE, AND NO DEVICE/LOT INFORMATION WAS PROVIDED. CAUSES FOR THE REPORTED DEATH COULD NOT BE DETERMINED. DEATH IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT THE PATIENT DEATHS. THIS ARTICLE DISCUSSES CLINICAL OUTCOMES AFTER MITRAL VALVE SURGERY IN FAILED MITRACLIP PROCEDURES. THE ARTICLE CONCLUDED THAT FAILURE OF MITRACLIP REPRESENTS A CHALLENGING SITUATION LIMITED BY HIGH-RISK PROFILES OF PATIENTS AND LIMITS THE POSSIBILITY OF SURGICAL VALVE REPAIR, SHOWN BY A HIGH RATE OF MITRAL VALVE REPLACEMENT. SECONDARY SURGERY WAS ASSOCIATED WITH MODERATE 30 DAY AND POST DISCHARGE OUTCOMES. THEREFORE, A CAREFUL EVALUATION OF PATIENTS UNDERGOING MITRACLIP IS OF PARAMOUNT IMPORTANCE. COMPLICATIONS NOTED AFTER THE MITRACLIP PROCEDURES SPECIFICALLY FOR THE MITRACLIP DEVICE INCLUDED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), REHOSPITALIZATION, MITRAL REGURGITATION, MITRAL STENOSIS, TISSUE DAMAGE, PERICARDIAL EFFUSION, ENDOCARDITIS, EDEMA, RESPIRATORY FAILURE, RENAL FAILURE, RE-CLIPPING, SURGICAL INTERVENTION, SURGICAL REPAIR AND PATIENT DEATHS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED ¿MITRAL VALVE SURGERY AFTER FAILED MITRACLIP-OPERATION FOR THE INOPERABLE?¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381223 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death