BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 4592226 · Received March 11, 2015

    Report

    Report Number
    2025587-2015-00309
    Event Type
    Death
    Date Received
    March 11, 2015
    Date of Event
    December 6, 2014
    Report Date
    April 2, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PERCUTANEOUS AORTIC VALVE (PAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT ALMOST 14 MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DIED IN HOSPICE CARE. THE CAUSE OF DEATH WAS VALVULAR HEART DISEASE. IT WAS REPORTED THAT THE DEATH WAS POSSIBLY RELATED TO THE VALVE. AN AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168264 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00095 YR Death