BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19278420 · Received May 9, 2024

    Report

    Report Number
    2135147-2024-02068
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    June 30, 2021
    Report Date
    July 3, 2024
    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

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECT OF DEATH REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE ATTACHMENT: CARDIAC DAMAGE IN DEGENERATIVE MITRAL REGURGITATION TREATED WITH TRANSCATHETER MITRAL EDGE-TO-EDGE REPAIR A2: MEAN AGE A3: MAJORITY GENDER B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6A: DATE OF IMPLANT WAS ESTIMATED.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART/LOT INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE AND THE ARTICLE COVERING MULTIPLE PATIENTS, A CAUSE FOR THE REPORTED MITRAL VALVE INSUFFICIENCY/REGURGITATION (MR), HEART FAILURE/CONGESTIVE HEART FAILURE AND DEATH (NON-CARDIOVASCULAR, CARDIAC AND VASCULAR) CANNOT BE DETERMINED. HOWEVER, HEART FAILURE, MITRAL REGURGITATION AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT: ARTICLE TITLE: CARDIAC DAMAGE IN DEGENERATIVE MITRAL REGURGITATION TREATED WITH TRANSCATHETER MITRAL EDGE-TO-EDGE REPAIR A2: MEAN AGE A3: MAJORITY GENDER B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6A: DATE OF IMPLANT WAS ESTIMATED.

    Description of Event or Problem · 0

    THE ARTICLE TITLED, ¿CARDIAC DAMAGE IN DEGENERATIVE MITRAL REGURGITATION TREATED WITH TRANSCATHETER MITRAL EDGE-TO-EDGE REPAIR, WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTIPLE CENTER EXPERIENCE AIMED TO EVALUATE CARDIAC DAMAGE IN PATIENTS WITH DEGENERATIVE MITRAL REGURGITATION (MR) TREATED WITH TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) AND ITS ASSOCIATION WITH CLINICAL OUTCOMES. THE MITRACLIP WAS THE DEVICE USED FOR ALL TEER PROCEDURES. THE ARTICLE CONCLUDED THAT ADVANCED CARDIAC DAMAGE IS ASSOCIATED WITH AN INCREASED RISK OF MORTALITY IN PATIENTS UNDERGOING TEER FOR DEGENERATIVE MR. THE PRIMARY AUTHORS OF THE ARTICLE IS ATSUSHI SUGIURA, MD, PHD AND MASANORI YAMAMOTO, MD, PHD. THE CORRESPONDENCE AUTHOR IS ATSUSHI SUGIURA, MD, PHD, HEART CENTER BONN, DEPARTMENT OF MEDICINE II, UNIVERSITY HOSPITAL BONN, GERMANY, VENUSBERG-CAMPUS 1, 53127 BONN, GERMANY. EMAIL [email protected]. THE TIME FRAME OF THE STUDY WAS APRIL 2018 TO JUNE 2021. A TOTAL OF 579 PATIENTS WERE INCLUDED IN THIS STUDY. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 82. THE MAJORITY GENDER WAS FEMALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDE: CORONARY ARTERY DISEASE, PRIOR MYOCARDIAL INFARCTION, DEGENERATIVE MR, TRICUSPID REGURGITATION, ATRIAL FIBRILLATION, HEART FAILURE HOSPITALIZATION, HEART FAILURE, HEART FAILURE WITH PRIOR HOSPITALIZATION. PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED: 87 DEATHS (CARDIOVASCULAR CAUSES IDENTIFIED IN 48 PATIENTS AND NON-CARDIOVASCULAR DEATH IN 39 PATIENTS), HEART FAILURE HOSPITALIZATION, DEATH RELATED TO HEART FAILURE REHOSPITALIZATION, REPEAT MITRAL VALVE TREATMENT, AND MR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383868 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| R