BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19888021 · Received August 1, 2024

    Report

    Report Number
    2135147-2024-03731
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    June 1, 2016
    Report Date
    August 29, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND THE LIMITED INFORMATION FROM THE ARTICLE, THE CAUSE OF THE REPORTED BLEEDING, AND RENAL FAILURE WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECTS OF HEMORRHAGE, AND RENAL FAILURE, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. LITERATURE ATTACHMENT: ARTICLE TITLE: COMBINED USE OF MITRACLIP AND VENTRICULAR ASSIST DEVICES IN CARDIOGENIC SHOCK: MITRA-ASSIST REGISTRY

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: DATE OF EVENT ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. LITERATURE ATTACHMENT: "COMBINED USE OF MITRACLIP AND VENTRICULAR ASSIST DEVICES IN CARDIOGENIC SHOCK: MITRA-ASSIST REGISTRY".

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT FROM JUNE 2016 TO DECEMBER 2022, 24 PATIENTS UNDERWENT A COMBINED MITRACLIP AND OTHER TRANSCATHETER EDGE-TO-EDGE THERAPY (TEER) PRODUCT. THE IMPLANTED MITRACLIP MAY HAVE CAUSED OR CONTRIBUTE TO BLEEDING, KIDNEY FAILURE, AND PROLONGED HOSPITALIZATION. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿COMBINED USE OF MITRACLIP AND VENTRICULAR ASSIST DEVICES IN CARDIOGENIC SHOCK: MITRA-ASSIST REGISTRY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958006 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization