BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 18440049 · Received January 3, 2024

    Report

    Report Number
    2135147-2024-00035
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    January 1, 2023
    Report Date
    January 3, 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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW AND THE COMPLAINT HISTORY REVIEW WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION, THE REPORTED ENTRAPMENT OF DEVICE (CLIP CAUGHT ON CHORDAE) WAS DUE TO PROCEDURAL CIRCUMSTANCES (E.G., CLIP POSITIONING MANEUVER AT VALVE TO AVOID INTERFERENCE WITH LEAFLET CALCIFICATION). THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT IS ESTIMATED. ATTACHMENT: ARTICLE TITLED ¿PREOPERATIVE EVALUATION OF MITRAL VALVE CALCIFICATION USING ELECTROCARDIOGRAPHY-GATED 4-DIMENSIONAL COMPUTED TOMOGRAPHY FOR SAFER MITRACLIP PROCEDURE.¿

    Description of Event or Problem · 0

    THIS RESEARCH ARTICLE WAS A CASE STUDY DESIGNED TO EVALUATE USING PREOPERATIVE ELECTROCARDIOGRAPHY-GATED 4-DIMENSIONAL COMPUTED TOMOGRAPHY (4D-CT). A PROCEDURE WAS PERFORMED TO TREAT SEVERE DEGENERATIVE MITRAL REGURGITATION. A NTW MITRACLIP WAS ATTEMPTED TO BE IMPLANTED, BUT BECAME ENTANGLED WITH THE COMMISSURAL CHORDAE. THE CLIP WAS STILL ABLE TO BE DEPLOYED ON THE TARGET LEAFLETS. FOR FURTHER STABILIZATION AND FURTHER MR REDUCTION, A NT MITRACLIP WAS ALSO IMPLANTED. MR WAS MARKEDLY REDUCED WITH HEMODYNAMIC IMPROVEMENT. ON POSTOPERATIVE 4D-CT, BOTH CLIPS HAD BEEN SUCCESSFULLY POSITIONED WITHOUT GRASPING THE A3 CALCIFICATION IN CONCLUSION THIS CASE DEMONSTRATED THE NOVEL UTILITY OF ECG-GATED D-CT IN ASSESSING THE MV APPARATUS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, "PREOPERATIVE EVALUATION OF MITRAL VALVE CALCIFICATION USING ELECTROCARDIOGRAPHY-GATED 4-DIMENSIONAL COMPUTED TOMOGRAPHY FOR SAFER MITRACLIP PROCEDURE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627729 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention