BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 23660503 · Received November 26, 2025

    Report

    Report Number
    2135147-2025-06952
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    August 1, 2016
    Report Date
    November 26, 2025
    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 HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION. COMPLICATIONS REPORTED INCLUDED DEATH, STROKE, PERICARDIAL TAMPONADE, ACUTE KIDNEY INJURY, DIALYSIS, RE-INTERVENTION, BLEEDING, MYOCARDIAL INFARCTION; 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 "RESIDUAL MITRAL REGURGITATION AFTER TRANSCATHETER EDGE-TO-EDGE REPAIR WORSENS SURVIVAL IN PATIENTS WITH RENAL DYSFUNCTION" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE MULTI CENTER STUDY, TO EVALUATE THE IMPACT OF RESIDUAL MITRAL REGURGITATION (MR) ON 3-YEAR MORTALITY IN PATIENTS WITH OR WITHOUT CKD OR AKI. DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT RESIDUAL MR FOLLOWING TEER IS A STRONG PREDICTOR OF LONG-TERM MORTALITY, PARTICULARLY IN PATIENTS WITH CKD. MINIMIZING RESIDUAL MR MAY REDUCE POSTPROCEDURAL AKI AND IMPROVE SURVIVAL OUTCOMES IN PATIENTS WITH CKD. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS DENNIS ROTTLÄNDER AT DEPARTMENT OF CARDIOLOGY, SCHOOL OF MEDICINE, WITTEN/HERDECKE UNIVERSITY, WITTEN, GERMANY WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS AUGUST 2016 TO APRIL 2020. A TOTAL OF 1490 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 1490 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 INCLUDED HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION. (B)(4), UNK MITRACLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, STROKE, PERICARDIAL TAMPONADE, ACUTE KIDNEY INJURY, DIALYSIS, RE-INTERVENTION, BLEEDING, MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148167 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention