BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3623062 · Received February 11, 2014

    Report

    Report Number
    2024168-2014-00768
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ESTIMATED EVENT DATE (REPORTED AS UNK/UNK/2014). THE MITRACLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: DATE OF DEATH AND DATE OF EVENT CORRECTED FROM (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE WAS NO REPORTED DEVICE MALFUNCTION. THE ANALYSIS OF THIS COMPLAINT WAS AN ASSESSMENT OF THE MANUFACTURING RECORDS AND INFORMATION PROVIDED TO ABBOTT VASCULAR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS REPORTED LOT. THE REPORTED PATIENT EFFECTS OF DEATH, WORSENING HEART FAILURE AND RESPIRATORY FAILURE, 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED: ACCORDING TO THE DEATH CERTIFICATE, THE PATIENT DIED ON (B)(6) 2014. THE CAUSE OF DEATH WAS RESPIRATORY FAILURE AND CONGESTIVE HEART FAILURE. THE INVESTIGATOR (STUDY PHYSICIAN) HAS NOW REPORTED THAT HE IS UNABLE TO ASSESS THE DEVICE RELATIONSHIP TO THIS EVENT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED FINAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT'S DATE OF DEATH WAS ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS DEATH OCCURRED DURING A CLINICAL TRIAL AND THE PHYSICIAN'S RELATIONSHIP OF DEATH TO THE DEVICE HAS NOT BEEN PROVIDED. IT WAS REPORTED THAT, ON (B)(6) 2010, ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED REDUCING FUNCTIONAL MITRAL REGURGITATION (MR) FROM GRADE 4 TO 1. ON AN UNKNOWN DATE IN 2014 THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT PROVIDED. THE INVESTIGATOR'S ASSESSMENT OF RELATIONSHIP OF THE DEVICE TO THE DEATH WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89764 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10020401

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death