BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6076608 · Received November 3, 2016

    Report

    Report Number
    2025587-2016-01717
    Event Type
    Death
    Date Received
    November 3, 2016
    Date of Event
    October 12, 2016
    Report Date
    December 29, 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

    (B)(4). PRODUCT ANALYSIS: THE PRODUCT 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.

    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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE VALVE WAS POSITIONED A LITTLE D EEP. DURING RECAPTURE OF THE VALVE, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM SHOWED NO DISSECTIONS OR PERFORATIONS. THE ELECTROCARDIOGRAM (ECG) SHOWED VENTRICULAR TACHYCARDIA (VT) AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE DECISION WAS MADE TO IMPLANT THE VALVE DURING CPR, AND IT WAS SEATED PERFECTLY. VT OCCURRED AGAIN, FOR WHICH A SHOCK WAS DELIVERED. THE VALVE REMAINED IN PERFECT ANATOMICAL POSITION, HOWEVER, THE VENTRICLE WAS TOO WEAK TO PUMP AND THE PATIENT DIED. THEY PHYSICIAN REPORTED THE PATIENT HAD AN EJECTION FRACTION OF 22 AND THE DEATH WAS RELATED TO THE WEAK VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727668 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29-US

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death