BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT

    MDR report key: 6159140 · Received December 9, 2016

    Report

    Report Number
    2024168-2016-08762
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 9, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648216817
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. THE REPORTED PATIENT EFFECTS OF MITRAL VALVE DAMAGE, WORSENING MITRAL REGURGITATION AND HYPERTENSION, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, THE REPORTED PATIENT EFFECT OF TISSUE DAMAGE (LEAFLET TEAR) APPEARS TO BE RELATED TO PATIENT/PROCEDURAL CONDITIONS DUE TO MECHANICAL STRESS CAUSED BY HIGH BLOOD PRESSURE (HYPERTENSION); THE REPORTED WORSENING MR WAS LIKELY A SECONDARY EFFECT OF THE LEAFLET DAMAGE. THE REPORTED HYPERTENSION WAS LIKELY RELATED TO PATIENT CONDITIONS AS THE PATIENT HAD GOOD LEFT VENTRICULAR FUNCTION THE NIGHT AFTER THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE INCREASED MITRAL REGURGITATION (MR), WHICH WAS SUSPECTED TO BE DUE TO LEAFLET DAMAGE. IT WAS REPORTED THAT THE MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016, TO TREAT MIXED MR WITH A GRADE OF 3. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 1. THE NIGHT AFTER THE PROCEDURE, THE PATIENT HAD A PEEK IN THE SYSTOLIC BLOOD PRESSURE OF ABOUT 200 MMHG. THE LEFT VENTRICULAR FUNCTION WAS VERY GOOD. ECHOCARDIOGRAM ASSESSMENT (2D) WAS PERFORMED, AND IT WAS FOUND THAT THE MR HAD INCREASED TO 2. THERE APPEARED TO BE DAMAGE TO THE LEAFLET, CLOSE TO THE CLIP. IT IS THE PHYSICIANS OPINION THAT THE MECHANICAL STRESS OF THE HIGH BLOOD PRESSURE IN COMBINATION WITH THE GOOD LEFT VENTRICULAR FUNCTION CAUSED THE LEAFLET DAMAGE. THE PATIENT WAS CONFIRMED TO BE STABLE, AND IS PLANNED TO BE DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812595 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60825U171 08717648216817

    Patients

    Seq Age Sex Outcome Treatment
    1 Other