BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 24590415 · Received March 13, 2026

    Report

    Report Number
    2135147-2026-01612
    Event Type
    Death
    Date Received
    March 13, 2026
    Date of Event
    October 1, 2011
    Report Date
    March 13, 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 DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CORONARY ARTERY DISEASE, DIABETES, HYPERTENSION, PRIOR STROKE, PACEMAKER, ATRIAL FIBRILLATION. COMPLICATIONS REPORTED INCLUDED DEATH, MYOCARDIAL INFARCTION, BLEEDING; 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.

    Description of Event or Problem · 0

    THE ARTICLE "IMPACT OF RESIDUAL MODERATE MITRAL REGURGITATION AFTER TRANSCATHETER EDGE-TO-EDGE REPAIR ON LONG-TERM SURVIVAL: INSIGHTS FROM A MULTICENTER COHORT STUDY" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI CENTER STUDY, TO EVALUATE THE IMPACT OF RESIDUAL MODERATE MITRAL REGURGITATION AFTER TEER ON LONG TERM SURVIVAL. DEVICES MENTIONED INCLUDE MITRACLIP AND NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THATRESIDUAL MR OF II° OCCURRED IN 12% OF PATIENTS AND WAS MORE COMMON IN YOUNGER, COMORBID INDIVIDUALS WITH COMPLEX MR ANATOMY. WHILE SURVIVAL WAS UNAFFECTED IN THE OVERALL COHORT, AGE <65 YEARS EMERGED AS A KEY PREDICTOR OF SUBOPTIMAL MR REDUCTION. THESE FINDINGS HIGHLIGHT THE NEED FOR CRITICAL PATIENT SELECTION AND MAY INFORM INDIVIDUALIZED TREATMENT STRATEGIES IN CONTEMPORARY MTEER PRACTICE. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS ULRICH LUESEBRINK AT DEPARTMENT OF CARDIOLOGY, UNIVERSITY HOSPITAL MARBURG, BALDINGERSTRASSE MARBURG, MARBURG, GERMANY WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS OCTOBER 2011 TO DECEMBER 2022. A TOTAL OF 821 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 650 RECEIVED AN ABBOTT DEVICE. AS THIS EVENT IS FROM A LITERATURE REVIEW, THERE IS NO RELEVANT PATIENT INFORMATION (DATE OF BIRTH, AGE, GENDER, WEIGHT, AND MEDICAL HISTORY) TO REPORT. COMORBIDITIES INCLUDE CORONARY ARTERY DISEASE, DIABETES, HYPERTENSION, PRIOR STROKE, PACEMAKER, ATRIAL FIBRILLATION. (B)(4), UNK MITRACLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, MYOCARDIAL INFARCTION, BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125885 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death