BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 4270224 · Received November 21, 2014

    Report

    Report Number
    2025587-2014-00911
    Event Type
    Death
    Date Received
    November 21, 2014
    Date of Event
    June 8, 2014
    Report Date
    April 3, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. NO SPECIFIC ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS. A VARIETY OF FACTORS CAN INFLUENCE THE ONSET OF STROKE, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    IT WAS NOT REPORTED WHETHER AN AUTOPSY HAD BEEN PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT NINE MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DIED IN HOSPICE CARE AFTER DECLINING A FEEDING TUBE. THE CLINICAL STUDY EVENT COMMITTEE DETERMINED THE DEATH WAS RELATED TO THE DEVICE AND IMPLANT PROCEDURE AS A COMPLICATION OF A MIDDLE CEREBRAL ARTERY EMBOLIC STROKE THAT OCCURRED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755530 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death