BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 6832347 · Received August 30, 2017

    Report

    Report Number
    2025587-2017-01509
    Event Type
    Death
    Date Received
    August 30, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 9, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169954441
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT VALVES REMAIN IMPLANTED AND THE DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED BY THE CUSTOMER; THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED.   CONCLUSION: WITHOUT RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICES ARE: PRODUCT ID, [EVOLUTPRO-26-US], SERIAL/LOT (B)(4), USE BY DATE [2019-06-29], UDI [(B)(4)]. PRODUCT ID: [ENVEOR-N-US], SERIAL/LOT [(B)(4)], USE BY DATE [2018-05-12], UDI [(B)(4)]. 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 DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON RELEASE AT 1MM BELOW THE ANNUL US, THE VALVE DISLODGED TO -2MM ON THE NON-CORONARY AND -1MM ON THE LEFT CORONARY CUSPS DURING REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS). THE PHYSICIAN REPORTED THAT THE GUIDEWIRE CONTRIBUTED TO THE NOSE CONE NOT CENTERING FOLLOWING VALVE DEPLOYMENT AND MAY HAVE CONTRIBUTED TO THE DISLODGEMENT OF THE VALVE. SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED AND MULTIPLE BALLOON AORTIC VALVULOPLASTIES (BAV) WERE PERFORMED UNSUCCESSFULLY. THE PATIENT WENT INTO CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. CARDIOPULMONARY BYPASS (CPB) WAS INITIATED AND A SECOND TRANSCATHETER VALVE WAS IMPLANTED 5MM BELOW THE FIRST VALVE. SUBSEQUENTLY, A CORONARY OCCLUSION OCCURRED AND MULTIPLE ATTEMPTS TO CANNULATE THE CORONARY ARTERIES WERE UNSUCCESSFUL. CORONARY ARTERY BYPASS (CAB) WAS PERFORMED AND THE GRAFTS WERE IMPLANTED AT 10MM ABOVE THE ANNULUS. THE PATIENT WAS TRANSFERRED IN CRITICAL CONDITION AND EXPIRED IN THE RECOVERY ROOM DUE TO CARDIOGENIC EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612691 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26-US 00643169954441

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death