BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3914419 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04363
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    December 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION. THE REPORTED PATIENT EFFECTS OF MITRAL REGURGITATION AND ARRHYTHMIAS (BRADYCARDIA), AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS CDS (CLIP DELIVERY SYSTEM) REPORT IS BEING FILED FOR THE RECURRENT MR (MITRAL REGURGITATION) WHICH IS CONSIDERED A SERIOUS INJURY. IT WAS REPORTED THAT ON (B)(6) 2013 ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED REDUCING THE MR FROM GRADE 4 DOWN TO GRADE 0 TO 1. ONE DAY POST PROCEDURE THE PATIENT HAD SINUS BRADYCARDIA WITH A HEART RATE DOWN TO 40 BEATS PER MINUTE OVERNIGHT. THERE WAS NO TREATMENT PROVIDED AND THE CONDITION RESOLVED THE FOLLOWING DAY. THE PATIENT EXPERIENCED DIZZINESS ON (B)(6) 2014. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT THEN TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER INVESTIGATION. AT THE SIX MONTH FOLLOW-UP ECHOCARDIOGRAM ON (B)(6) 2014, THE MR WAS FOUND TO HAVE INCREASED TO 1+. THERE IS NO TREATMENT PLANNED AND THE MR INCREASE WAS NOT CONSIDERED A SERIOUS INJURY. THERE WERE NO PATIENT EFFECTS REPORTEDLY RELATED TO THE MR OF 1+. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390763 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10260615

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R