BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 20516160 · Received October 23, 2024

    Report

    Report Number
    2135147-2024-05252
    Event Type
    Death
    Date Received
    October 23, 2024
    Date of Event
    September 28, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE ATTACHMENT: ARTICLE TITLED ¿OUTCOMES OF MITRAL TRANSCATHETER EDGE TO EDGE REPAIR WITH MITRACLIP¿ ¿ AN INDIAN SINGLE CENTER EXPERIENCE¿.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, A CAUSE FOR THE REPORTED DEATH COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, THE REPORTED PATIENT EFFECT DEATH, AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE, ¿OUTCOMES OF MITRAL TRANSCATHETER EDGE TO EDGE REPAIR WITH MITRACLIP¿ ¿ AN INDIAN SINGLE CENTER EXPERIENCE¿, WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE OUTCOMES OF TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) WITH MITRACLIP (ABBOTT VASCULAR) IN SYMPTOMATIC HIGH SURGICAL RISK INDIAN PATIENTS WITH SIGNIFICANT MITRAL REGURGITATION (MR). PATIENTS WITH MODERATELY SEVERE OR SEVERE PRIMARY OR SECONDARY MR AND DEEMED HIGH SURGICAL RISK WERE TREATED WITH MITRACLIP. THE DATA WERE COLLECTED RETROSPECTIVELY FROM MEDICAL RECORDS. THE PRIMARY OUTCOME WAS TECHNICAL SUCCESS, AND SECONDARY OUTCOMES WERE =2+ MR REDUCTION AND IMPROVEMENT IN FUNCTIONAL CAPACITY AT 30 DAYS. BETWEEN NOVEMBER 2018 AND AUGUST 2023, 64 PATIENTS WERE TREATED WITH MITRACLIP. THE ARTICLE CONCLUDED THAT IN HIGH-RISK INDIAN PATIENTS WITH SYMPTOMATIC SIGNIFICANT MR, TEER WITH MITRACLIP¿ WAS ACHIEVED WITH A HIGH TECHNICAL SUCCESS RATE. IT WAS ASSOCIATED WITH SIGNIFICANT REDUCTION IN MR SEVERITY AND IMPROVEMENT IN FUNCTIONAL CAPACITY IN >90 % OF THE SUBJECTS. THE PRIMARY AUTHOR OF THE ARTICLE IS SAI SATISH, CARDIOLOGICAL SOCIETY OF INDIA. THE CORRESPONDENCE AUTHOR IS VIJAYAKUMAR SUBBAN. CORRESPONDING EMAIL: [email protected]. BETWEEN (B)(6) 2023, 64 PATIENTS WERE TREATED WITH A MITRACLIP. THE MEAN AGE WAS 70.0 ± 12.1 YEARS AND 64 % WERE MALES. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED: CORONARY ARTERY DISEASE, PREVIOUS CORONARY ARTERY BYPASS GRAFTING (CABG), ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE. ADVERSE EVENT INCLUDED: THE MITRACLIP MAY HAVE CAUSED OR CONTRIBUTE TO DEATH, AIR EMBOLISM, CARDIAC TAMPONADE, HEART FAILURE, MYOCARDIAL INFARCTION, RENAL FAILURE, RECURRENT MR, HOSPITALIZATION, AND MEDICAL INTERVENTION. THE STEERABLE GUIDE CATHETER (SGC) CAUSED OR CONTRIBUTED TO ATRIAL SEPTAL DEFECTS, REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33267 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death