BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19614158 · Received June 26, 2024

    Report

    Report Number
    2135147-2024-03018
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    July 1, 2023
    Report Date
    July 15, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTACHMENT: ARTICLE TITLED ¿INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿ 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, THE CAUSE OF THE REPORTED DIFFICULT LEAFLET GRASPING AND TISSUE INJURY WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECT OF TISSUE INJURY, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED SERIOUS INJURY/ ILLNESS/ IMPAIRMENT WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    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 IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6: DATE OF IMPLANT ESTIMATED. ATTACHMENT: ARTICLE TITLED ¿INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿.

    Description of Event or Problem · 0

    THE ARTICLE, ¿INDICATIONS AND OUTCOMES OF THE MITRACLIP G4 DEVICE WITH CONTROLLED GRIPPER ACTUATION SYSTEM¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN XTW CLIP WAS CHOSEN FOR IMPLANT FOR MITRAL VALVE REPAIR. THE PATIENT HAD DEGENERATIVE MITRAL REGURGITATION. DURING PROCEDURE, CONTROLLED GRIPPER ACTUATION WAS INDICATED FOR GRASPING DUE TO FLAIL LEAFLET. THE ARTICLE CONCLUDED THAT INDICATIONS OF CGA DURING THE TEER PROCEDURE CAN BE DIVIDED INTO (1) CGA FOR GRASPING AND (2) CGA FOR CONFIRMATION OF LEAFLET INSERTION. IN PATIENTS WITH COMPLEX MITRAL VALVE ANATOMY, CGA MAY BE A SAFE AND EFFECTIVE METHOD FOR CONFIRMING LEAFLET INSERTION. IT SHOULD BE NOTED THAT WHEN USING CGA FOR LEAFLET GRASPING, ESPECIALLY WHEN THE CLIP IS MOVED SIGNIFICANTLY, ATTENTION SHOULD BE PAID TO LEAFLET ADVERSE EVENTS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS (B)(6)] TISSUE DAMAGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579073 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other