BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6078656 · Received November 4, 2016

    Report

    Report Number
    2025587-2016-01726
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 27, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING A BALLOON AORTIC VALVULOPLASTY (BAV), THE LEFT CORONARY ARTERY BECAME OCCLUDED CAUSING A MYOCARDIAL INFARCTION (MI). THE PATIENT WENT INTO DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND BLOOD PRODUCTS WERE GIVEN IN AN ATTEMPT TO REVERSE THE DIC. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AND EMERGENCY BYPASS SURGERY WAS PERFORMED. THE FOLLOWING DAY A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED NO RIGHT VENTRICLE (RV) FUNCTION, LEFT VENTRICLE DILATION AND EJECTION FRACTION LESS THAN 10%. THE PATIENT DID NOT RECOVER AND EXPIRED AS A RESULT OF THE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730157 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29-C

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death