BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 22925794 · Received August 29, 2025

    Report

    Report Number
    2135147-2025-04880
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    April 1, 2015
    Report Date
    August 29, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, PREVIOUS STROKE OR TIA, PORCELAIN AORTA, SMOKER, DIABETES, DIALYSIS, CHRONIC LUNG DISEASE, HEART FAILURE, HOSPITALIZATION, PERIPHERAL VASCULAR DISEASE, PERMANENT PACEMAKER, CARDIAC RESYNCHRONIZATION THERAPY, ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION, CABG, AORTIC VALVE REPLACEMENT, PERCUTANEOUS CORONARY INTERVENTION, DEGENERATIVE MITRAL REGURGITATION, FUNCTIONAL MITRAL REGURGITATION, AORTIC REGURGITATION, TRICUSPID REGURGITATION, MITRAL ANNULAR CALCIFICATION. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE HOSPITALIZATION, VALVE REINTERVENTION, SURGICAL INTERVENTION, RECURRENT MITRAL REGURGITATION, STROKE, MITRAL STENOSIS, AND TRICUSPID INTERVENTION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B3: EVENT DATE IS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: PROGNOSTIC SIGNIFICANCE OF MITRAL ANNULAR CALCIFICATION ASSESSED BY COMPUTED TOMOGRAPHY FOR TRANSCATHETER EDGE-TO-EDGE REPAIR OUTCOMES.

    Description of Event or Problem · 0

    THE ARTICLE "PROGNOSTIC SIGNIFICANCE OF MITRAL ANNULAR CALCIFICATION ASSESSED BY COMPUTED TOMOGRAPHY FOR TRANSCATHETER EDGE-TO-EDGE REPAIR OUTCOMES" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE THE ASSOCIATION BETWEEN CT FEATURES OF MITRAL ANNULAR CALCIFICATION (MAC) AND CLINICAL OUTCOMES AFTER TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) AT 3 YEARS.. DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT ALL-CAUSE MORTALITY DID NOT SIGNIFICANTLY DIFFER BETWEEN PATIENTS WITH VARIED MAC SEVERITY. HOWEVER, GREATER CALCIUM THICKNESS AND LEAFLET INVOLVEMENT WERE ASSOCIATED WITH WORSE CLINICAL OUTCOMES IN PATIENTS UNDERGOING TEER. DETAILED PREOPERATIVE CT EVALUATION CAN FACILITATE THE PREDICTION AND MANAGEMENT OF TEER OUTCOMES. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS RAJ MAKKAR AT CEDARS-SINAI MEDICAL CENTER, LOS ANGELES, CALIFORNIA, USA WITH CORRESPONDING EMAIL: [email protected]. THE TIME FRAME OF THE STUDY WAS APRIL 2015 AND MARCH 2021. A TOTAL OF 391 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH ALL RECEIVED AN ABBOTT DEVICE. AVERAGE AGE WAS 74 AND MAJORITY SEX WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, PREVIOUS STROKE OR TIA, PORCELAIN AORTA, SMOKER, DIABETES, DIALYSIS, CHRONIC LUNG DISEASE, HEART FAILURE HOSPITALIZATION, PERIPHERAL VASCULAR DISEASE, PERMANENT PACEMAKER, CARDIAC RESYNCHRONIZATION THERAPY, ATRIAL FIBRILLATION, MYOCARDIAL INFARCTION, CABG, AORTIC VALVE REPLACEMENT, PERCUTANEOUS CORONARY INTERVENTION, DEGENERATIVE MITRAL REGURGITATION, FUNCTIONAL MITRAL REGURGITATION, AORTIC REGURGITATION, TRICUSPID REGURGITATION, MITRAL ANNULAR CALCIFICATION. COMPLICATIONS INCLUDED DEATH, HEART FAILURE HOSPITALIZATION, VALVE REINTERVENTION, SURGICAL INTERVENTION, RECURRENT MITRAL REGURGITATION, STROKE, MITRAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213188 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H| S| R