BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 25050604 · Received April 30, 2026

    Report

    Report Number
    2135147-2026-02888
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    January 1, 2018
    Report Date
    April 30, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, SYNCOPE, HEART FAILURE, CHRONIC KIDNEY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MITRAL REGURGITATION, AND PREVIOUS STROKE, CORONARY ARTERY BYPASS GRAFT, PERCUTANEOUS CORONARY INTERVENTION, MYECTOMY, SEPTAL ABLATION, PACEMAKER IMPLANT, AND IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. COMPLICATIONS REPORTED INCLUDED INCOMPLETE COAPTATION, ENTRAPMENT OF DEVICE, MITRAL INSUFFICIENCY/REGURGITATION, UNEXPECTED MEDICAL INTERVENTION (ADDITIONAL PROCEDURE, MITRACLIP IMPLANTED), HOSPITALIZATION/PROLONGED-HOSPITALIZATION, DEATH; 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.LITERATURE ATTACHMENT: TRANSCATHETER EDGE-TO-EDGE REPAIR FOR SAM-RELATED MITRAL REGURGITATION IN PATIENTS WITH HCM: THE TRANSPARENT REGISTRYB3: EVENT DATE WAS ESTIMATEDD4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "TRANSCATHETER EDGE-TO-EDGE REPAIR FOR SAM-RELATED MITRAL REGURGITATION IN PATIENTS WITH HCM: THE TRANSPARENT REGISTRY", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES OF PATIENTS UNSUITABLE FOR SURGERY WITH LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION (LVOTO) AND SEVERE OR MODERATE-TO-SEVERE MITRAL REGURGITATION (MR) DUE TO SYSTOLIC ANTERIOR MOTION (SAM) TREATED BY MEANS OF MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER). THE DEVICE INCLUDED IN THE STUDY WAS MITRACLIP. THE ARTICLE CONCLUDED THAT M-TEER APPEARS TO BE A FEASIBLE AND SAFE THERAPEUTIC OPTION FOR ANATOMICALLY SUITABLE PATIENTS WITH OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM), LVOTO, AND SAM-RELATED MR WHO ARE AT HIGH OR PROHIBITIVE SURGICAL RISK. [THE PRIMARY AND CORRESPONDING AUTHOR WAS LUCA TESTA, IRCCS POLICLINICO SAN DONATO, PIAZZA E. MALAN 2, 20097 SAN DONATO MILANESE, MILAN, ITALY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WITH OBSTRUCTIVE HCM, SIGNIFICANT SAM AND MODERATE-TO-SEVERE OR SEVERE MR DESPITE OPTIMAL MEDICAL THERAPY, WHO UNDERWENT M-TEER FROM 01 JANUARY 2018 TO 31 DECEMBER 2024. A TOTAL OF 35 PATIENTS WERE INCLUDED IN THE STUDY, ALL OF WHICH RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 69.3 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, SYNCOPE, HEART FAILURE, CHRONIC KIDNEY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, MITRAL REGURGITATION, AND PREVIOUS STROKE, CORONARY ARTERY BYPASS GRAFT, PERCUTANEOUS CORONARY INTERVENTION, MYECTOMY, SEPTAL ABLATION, PACEMAKER IMPLANT, AND IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62093 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1