BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3790638 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02819
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 27, 2014
    Report Date
    April 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LAB TESTS: (B)(6) 2014: TTE = MR SEVERITY (1+) MILD, MITRAL VALVE MEAN GRADIENT 3.4 MMHG; (B)(6) 2014: ELECTROCARDIOGRAM(ECG); (B)(6) 2014: TTE = MR SEVERITY (2+) MODERATE, MITRAL VALVE MEAN GRADIENT 4 MMHG, LEFT VENTRICULAR EJECTION FRACTION 32%, NO INCREASE IN LEFT VENTRICLE. SIZE. MITRACLIP FIRMLY SEATED. THE MITRACLIP REMAINS IN THE ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CDS. THE REPORTED PATIENT EFFECTS OF WORSENING MR AND DYSPNEA, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE STUDY PHYSICIAN NOW INDICATES THAT THE MITRACLIP DEVICE IS NOT RELATED TO THE WORSENING MITRAL REGURGITATION.

    Description of Event or Problem · 1

    THIS MITRACLIP DELIVERY SYSTEM REPORT IS BEING FILED FOR THE RECURRENT MITRAL REGURGITATION (MR). IT WAS REPORTED THAT ONE MITRACLIP WAS IMPLANTED ON (B)(4) 2014 REDUCING THE MR FROM 4+ DOWN TO 1+. THE PATIENT HAD TWO OCCASIONS OF WORSENING VOLUME OVERLOAD ON (B)(6) 2014 WITH AN INCREASE IN THE PATIENT WEIGHT. THE VOLUME OVERLOAD IMPROVED WITH MEDICATION AND THE HOSPITALIZATION WAS PROLONGED WITH THE FIRST INCIDENT OF OVERLOAD. THE 30 DAY TRANSTHORACIC ECHOCARDIOGRAM ON (B)(6) 2014, FOUND MR INCREASED FROM 1+ TO 2+ WITH THE MITRACLIP FIRMLY SEATED. THE PATIENT HAD SYMPTOMS OF FATIGUE AND ORTHOPNEA. THERE IS NO INTERVENTION PLANNED AT THIS TIME. THE PATIENT WILL BE MONITORED. THIS MR INCREASE WAS LISTED BY THE STUDY SITE AS POSSIBLY DEVICE RELATED. THE PHYSICIAN REPORTED THAT MEDICALLY UNDERTREATED CONGESTIVE HEART FAILURE WAS THE CAUSE OF THE RECURRENT MR. PART OF THE UNDER-TREATMENT WAS DUE TO THE PATIENT'S NON-COMPLIANCE. THE PATIENT'S MEDICATIONS FOR CONGESTIVE HEART FAILURE WERE ADJUSTED AND THE VOLUME OVERLOAD HAS IMPROVED. THE FATIGUE AND ORTHOPNEA RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269388 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10276655

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other