BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4233799 · Received November 6, 2014

    Report

    Report Number
    2024168-2014-07270
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    March 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    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). THE DEVICE WAS NOT RETURNED AND THERE WAS NO REPORTED DEVICE MALFUNCTION. THE REPORTED PATIENT EFFECTS OF DYSPNEA, FEVER, WORSENING MITRAL REGURGITATION (MR) AND ENDOCARDITIS, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, THE CAUSE FOR THE DYSPNEA AND FEVER WERE LIKELY DUE TO THE PRIMARY EFFECTS OF WORSENING MR AND ENDOCARDITIS; HOWEVER, A DEFINITIVE CAUSE FOR THESE PRIMARY 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. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE MITRACLIP IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS SUBMITTED TO REPORT INFECTIVE ENDOCARDIS WHICH OCCURRED AFTER THE MITRACLIP WAS IMPLANTED AND REQUIRED MITRAL VALVE REPLACEMENT. IT WAS REPORTED VIA LITERATURE REVIEW THAT A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2014, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3+. IT WAS NOTED THAT THE PATIENT HAD SHORTNESS OF BREATH, A POSTERIOR LEAFLET FLAIL AND ENLARGED LEFT ATRIUM. TWO CLIPS (10286145/(B)(4), 10282305/(B)(4)) WERE IMPLANTED AND THE MR WAS REDUCED TO TRACE. THE PATIENT WAS STARTED ON A STANDARD ANTIBIOTIC REGIME AND DISCHARGED 7 DAYS POST-PROCEDURE. ON (B)(6) 2014, 33 DAYS POST PROCEDURE, THE PATIENT WAS RE-ADMITTED WITH FEVER AND RECURRENCE OF SHORTNESS OF BREATH. BLOOD RESULTS FOUND ELEVATED INFLAMMATORY PARAMETERS, AND ECHOCARDIOGRAM SHOWED SEVERE MR DUE TO ULCERATION IN THE REGION OF THE POSTERIOR LEAFLET. THERE WAS A LARGE VEGETATION WITHIN THE CLIP REGION. THE CLIPS WERE CONFIRMED TO BE SECURELY ATTACHED TO BOTH LEAFLETS. BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS, DUE TO INFECTIVE ENDOCARDITIS, AND ANTIBIOTIC REGIME WAS STARTED. SURGICAL MITRAL VALVE REPLACEMENT WAS DONE ON (B)(6) 2014. POST-OPERATIVELY, THERE WAS NO MITRAL REGURGITATION AND THE PATIENT WAS DISCHARGED 15 DAYS POST-PROCEDURE. THE ANTIBIOTICS WERE CONTINUED FOR 6 ADDITIONAL WEEKS. IT IS THE PHYSICIANS OPINION THAT THE MITRACLIP DEVICE/PROCEDURE MAY HAVE BEEN CONTRIBUTORY TO THE ENDOCARDITIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715808 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10286145

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R| S 1 IMPLANTED MITRACLIP (10282305/(B)(4))