BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6038883 · Received October 19, 2016

    Report

    Report Number
    2024168-2016-07067
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 31, 2016
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE CLIP DELIVERY SYSTEM WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EFFECT OF DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR MEDICAL AFFAIRS DIRECTOR. THE REVIEWER NOTED THAT THE DEATH IS NEITHER DEVICE NOR PROCEDURE-RELATED AS STROKE WAS MOST LIKELY RELATED TO AIR ENTRY DURING CATHETER REMOVAL AND DEATH WAS MOST PROBABLY A CONSEQUENCE OF STROKE. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH COULD NOT BE DETERMINED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS CONSERVATIVELY FILED TO REPORT THAT 4 DAYS POST PROCEDURE THE PATIENT DIED. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016, TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS (60511U108, 60511U227) WERE IMPLANTED, REDUCING THE MR TO 2. THE PATIENT WAS STABLE POST-PROCEDURE. ON (B)(6) 2016, ONE DAY AFTER RETRACTING THE CENTRAL VENOUS CATHETER, THE PATIENT EXPERIENCED A STROKE. MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTERIZED TOMOGRAPHY (CT) SCANS WERE PERFORMED WHICH IDENTIFIED AN AIR EMBOLISM IN BRAIN, CAUSED BY EXTRACTION OF THE CENTRAL VENUS CATHETER. ON (B)(6) 2016, ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED THAT BOTH CLIPS WERE SECURE ON THE LEAFLETS. ON (B)(6) 2016, THE PATIENT DIED; HOWEVER, THE CAUSE OF DEATH COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692096 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60511U108

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ONE ADDITIONAL IMPLANTED MITRACLIP