BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 24888748 · Received April 15, 2026

    Report

    Report Number
    2135147-2026-02452
    Event Type
    Death
    Date Received
    April 15, 2026
    Date of Event
    August 1, 2017
    Report Date
    April 15, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MITRACLIP DELIVERY SYSTEM WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, DIABETES MELLITUS, HEART FAILURE, MITRAL REGURGITATION, AND TRICUSPID REGURGITATION. COMPLICATIONS REPORTED INCLUDED HEART FAILURE, 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: RESIDUAL LEFT ATRIAL V WAVE PREDICTS CLINICAL OUTCOME OF TRANSCATHETER EDGE-TO-EDGE MITRAL VALVE REPAIR B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "RESIDUAL LEFT ATRIAL V WAVE PREDICTS CLINICAL OUTCOME OF TRANSCATHETER EDGE-TO-EDGE MITRAL VALVE REPAIR", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE SINGLE-CENTER EXPERIENCE TO EVALUATE THE INTRAPROCEDURAL CHANGES IN LEFT ATRIAL V WAVE PRESSURE (LAVP) AND THEIR RELATIONSHIP WITH LONG-TERM CLINICAL OUTCOMES FOLLOWING MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER). THE DEVICES INCLUDED IN THE STUDY WERE MITRACLIP AND PASCAL. THE ARTICLE CONCLUDED THAT HIGH LAVP AFTER DEVICE IMPLANTATION IS AN INDEPENDENT PREDICTOR OF MORTALITY OR HOSPITALIZATION FOR HEART FAILURE FOLLOWING M-TEER IN PATIENTS WITH BOTH PRIMARY AND SECONDARY MITRAL REGURGITATION (MR). RESIDUAL LAVP BELOW 25MMHG IS CORRELATED WITH IMPROVED CLINICAL OUTCOMES, BOTH IN THE SETTING OF MILD OR MODERATE RESIDUAL MR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MICHAEL PAULUS, DEPARTMENT OF INTERNAL MEDICINE II UNIVERSITY HOSPITAL REGENSBURG FRANZ-JOSEF-STRAUSS-ALLEE 11, 93053 REGENSBURG, GERMANY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS UNDERGOING M-TEER FOR PRIMARY OR SECONDARY MR FROM 01 AUGUST 2017 TO 31 MARCH 2024. A TOTAL OF 299 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 68.9% (206) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 76.6 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, DIABETES MELLITUS, HEART FAILURE, MITRAL REGURGITATION, AND TRICUSPID REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943686 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death