BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 23237853 · Received October 7, 2025

    Report

    Report Number
    2135147-2025-05711
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 7, 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 ATRIAL FIBRILLATION/FLUTTER, ACUTE HEART FAILURE, CARDIOGENIC SHOCK, OR REQUIRED HEMODYNAMIC SUPPORT, STAGE =III CHRONIC KIDNEY DISEASE, ANEMIA, AND PRIOR MYOCARDIAL INFARCTION, PCI, OR CABG. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE HOSPITALIZATION, RECURRENT MITRAL REGURGITATION, THROMBOTIC OR BLEEDING EVENTS, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, LEAFLET INJURY, ARRHYTHMIA; 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. CORRELATES AND PROGNOSTIC VALUE OF LEFT ATRIAL STRAIN IN TRANSCATHETER EDGE-TO-EDGE REPAIR FOR DEGENERATIVE MITRAL REGURGITATION.

    Description of Event or Problem · 0

    THE ARTICLE "CORRELATES AND PROGNOSTIC VALUE OF LEFT ATRIAL STRAIN IN TRANSCATHETER EDGE-TO-EDGE REPAIR FOR DEGENERATIVE MITRAL REGURGITATION.PDF" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE-CENTER STUDY TO EVALUATE THE PROGNOSTIC SIGNIFICANCE OF LEFT ATRIAL STRAIN (LAS) IN PATIENTS UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) FOR DEGENERATIVE MITRAL REGURGITATION (DMR). DEVICES MENTIONED INCLUDE "MITRACLIP¿ (ABBOTT VASCULAR INC, SANTA CLARA, CA)". THE ARTICLE CONCLUDED THAT WORSE LAS AT BASELINE (<18.5%) AND AT 1-MONTH POST-PROCEDURE (<29%) WAS ASSOCIATED WITH HIGHER RISK OF DEATH AND HEART FAILURE HOSPITALIZATIONS, DESPITE HIGH PROCEDURAL SUCCESS, AND MAY SERVE AS A VALUABLE TOOL FOR RISK STRATIFICATION IN TEER CANDIDATES. THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS RAJ R MAKKAR AT DEPARTMENT OF CARDIOLOGY, SMIDT HEART INSTITUTE, CEDARS-SINAI MEDICAL CENTER WITH CORRESPONDING EMAIL [email protected]. THE TIME FRAME OF THE STUDY WAS JANUARY 1, 2013 TO DECEMBER 31, 2022. A TOTAL OF 367 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 367 RECEIVED AN ABBOTT DEVICE. RELEVANT MEDICAL HISTORY INCLUDED: MEDIAN AGE 82 YEARS, 62.4% MALE, 51.8% HAD ATRIAL FIBRILLATION/FLUTTER, 14.2% PRESENTED WITH ACUTE HEART FAILURE, CARDIOGENIC SHOCK, OR REQUIRED HEMODYNAMIC SUPPORT, 69.7% HAD STAGE =III CHRONIC KIDNEY DISEASE, 53.2% HAD ANEMIA, AND 29.2% HAD PRIOR MYOCARDIAL INFARCTION, PCI, OR CABG. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE HOSPITALIZATION, RECURRENT MITRAL REGURGITATION, THROMBOTIC OR BLEEDING EVENTS, PERICARDIAL EFFUSION, CARDIAC TAMPONADE, LEAFLET INJURY, ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690239 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H