BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 15537110 · Received October 4, 2022

    Report

    Report Number
    2135147-2022-01470
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATE OF EVENT: DATE ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. ATTACHMENT: ARTICLE TITLED, "TRANSCATHETER MITRAL VALVE REPAIR TECHNIQUE IN SPECIFIC SEVERE MITRAL REGURGITATION: TIPS, TRICKS, AND OUTCOMES".

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE CAUSE OF THE REPORTED RECURRENT MR WAS UNABLE TO BE CONFIRMED. THE REPORTED PATIENT EFFECT OF MITRAL REGURGITATION, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT RECURRENT MITRAL REGURGITATION REQUIRING INTERVENTION. THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY AIMED TO EVALUATE THE FEASIBILITY AND SAFETY OF A NEW TRANSCATHETER MITRAL VALVE (MV) REPAIR TECHNIQUE, USING OCCLUDER DEVICES IN SYMPTOMATIC HIGH-SURGICAL-RISK PATIENTS WITH SEVERE MITRAL REGURGITATION (MR), EITHER DUE TO MV LEAFLET (MVL) PATHOLOGY SUCH AS PERFORATIONS OR DUE TO POST-CLIPS RESIDUAL MR, AND TO REPORT ON THEIR 6-MONTH OUTCOMES. THE STUDY ENROLLED 16 PATIENTS; WITH MVL PERFORATIONS OR POST-MITRACLIP MR FROM NOVEMBER 2016 TO AUGUST 2019. AMONG THE 7 PATIENTS WITH POST-MITRACLIP RESIDUAL MR (AFTER IMPLANTATION OF 2 OR MORE MITRACLIP DEVICES), THREE PATIENTS HAD COMMISSURAL RESIDUAL MR BETWEEN MITRACLIP DEVICES AND ONE OF THE COMMISSURES. FOUR PATIENTS HAD INTER-CLIP RESIDUAL MR BETWEEN THE MITRACLIP ITSELF. ALL PATIENTS WERE CLOSED WITH AN AMPLATZER DEVICE. NO PATIENT WAS CONVERTED TO OPEN HEART SURGERY OR EXHIBITED DEVICE-RELATED COMPILATIONS OR PROCEDURE-RELATED MORTALITY. IN CONCLUSION, TRANSCATHETER MV REPAIR OF MVL PERFORATIONS/POST-CLIPS RESIDUAL MR IS A NEW, FEASIBLE, AND SAFE TECHNIQUE FOR HIGH-SURGICAL-RISK PATIENTS. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE LISTED IN THE ARTICLE TITLED, "TRANSCATHETER MITRAL VALVE REPAIR TECHNIQUE IN SPECIFIC SEVERE MITRAL REGURGITATION: TIPS, TRICKS, AND OUTCOMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395397 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H