BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 20714264 · Received November 18, 2024

    Report

    Report Number
    2135147-2024-05836
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    July 1, 2014
    Report Date
    November 18, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED WORSENING MR, RECURRENT MR, DEATH, AND HEART FAILURE. MR, DEATH, AND HEART FAILURE ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE ¿EVALUATION OF EXPANDED MITRAL REGURGITATION GRADING IN PATIENTS UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR¿ WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTIPLE CENTER EXPERIENCE TO EVALUATE HOW AN EXPANDED MITRAL REGURGITATION (MR) GRADING SYSTEM THAT INCLUDES CATEGORIES OF MASSIVE AND TORRENTIAL WOULD REGRADE PATIENTS UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) FOR MR AND EVALUATE PROCEDURAL OUTCOMES. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS USED TO ASSESS THE QUANTITATIVE SEVERITY OF MR AND RECLASSIFY REGURGITATION INTO SEVERE, MASSIVE, AND TORRENTIAL GRADES. SIMILARLY, RESIDUAL MR WAS ASSESSED POST PROCEDURALLY. BETWEEN JULY 2014 AND MARCH 2021, 142 PATIENTS WITH SEVERE MR WERE TREATED WITH A MITRACLIP. THE ARTICLE CONCLUDED THAT AN EXPANDED GRADING SYSTEM DEMONSTRATED THAT PATIENTS WITH MASSIVE AND TORRENTIAL MR STILL ACHIEVE ADEQUATE PROCEDURAL SUCCESS AND REDUCTION IN REGURGITATION AND IMPROVEMENT IN HEALTH STATUS. FURTHER EVALUATION OF HOW AN EXPANDED MR GRADING SCALE MAY BE USEFUL IS WARRANTED. THE PRIMARY AUTHOR OF THE ARTICLE IS ANDREW GUSTAFSON. THE CORRESPONDENCE AUTHOR IS AKHIL NARANG. CORRESPONDING EMAIL: [email protected]. BETWEEN JULY 2014 AND MARCH 2021, 142 PATIENTS WERE TREATED WITH A MITRACLIP. THE MEAN AGE WAS 81 YEARS AND 46% WERE FEMALES. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED: DEGENERATIVE MITRAL REGURGITATION, FUNCTIONAL MITRAL REGURGITATION, MIXED MITRAL REGURGITATION, DIABETES, DYSLIPIDEMIA, HYPERTENSION, CHRONIC KIDNEY DISEASE (CKD), CEREBROVASCULAR DISEASE (CVD), PRIOR MYOCARDIAL INFARCTION (MI), PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI), ATRIAL FIBRILLATION (AFIB), AND ATRIAL FLUTTER (AFLUTTER). ADVERSE EVENTS INCLUDED: RECURRENT MITRAL REGURGITATION, WORSENED MITRAL REGURGITATION, HEART FAILURE, HOSPITALIZATION, AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591989 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death