BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 23525812 · Received November 11, 2025

    Report

    Report Number
    2135147-2025-06536
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    March 1, 2018
    Report Date
    November 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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, HEMODIALYSIS, ATRIAL FIBRILLATION. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION; 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 "PROGNOSTIC IMPACT OF MITRAL VALVE SPHERICITY INDEX AFTER MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR IN FUNCTIONAL MITRAL REGURGITATION" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE THE IMPACT OF MV MORPHOLOGICAL PARAMETERS ON THE MID-TERM PROGNOSIS OF PATIENTS WITH FUNCTIONAL MR (FMR). DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT A LARGER POST-PROCEDURAL SI-MV IS ASSOCIATED WITH INCREASED MID-TERM ADVERSE CLINICAL EVENTS AFTER MV-TEER IN PATIENTS WITH FMR. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS CHIHIRO KOYANAGI AT TOKYO WOMEN¿S MEDICAL UNIVERSITY INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS MARCH 2018 TO MARCH 2022. A TOTAL OF 106 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 106 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, HEMODIALYSIS, ATRIAL FIBRILLATION. (B)(4), UNK MITRACLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    THE ARTICLE "PROGNOSTIC IMPACT OF MITRAL VALVE SPHERICITY INDEX AFTER MITRAL VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR IN FUNCTIONAL MITRAL REGURGITATION" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE THE IMPACT OF MV MORPHOLOGICAL PARAMETERS ON THE MID-TERM PROGNOSIS OF PATIENTS WITH FUNCTIONAL MR (FMR). DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT A LARGER POST-PROCEDURAL SI-MV IS ASSOCIATED WITH INCREASED MID-TERM ADVERSE CLINICAL EVENTS AFTER MV-TEER IN PATIENTS WITH FMR. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS CHIHIRO KOYANAGI AT TOKYO WOMEN¿S MEDICAL UNIVERSITY INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS MARCH 2018 TO MARCH 2022. A TOTAL OF 106 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 106 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, HEMODIALYSIS, ATRIAL FIBRILLATION. (B)(4), UNK MITRACLIP, PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645026 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| D| H