BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 6094726 · Received November 10, 2016

    Report

    Report Number
    2025587-2016-01772
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 16, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE RECEIVED AND ADDED TO THIS REPORT.

    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

    WITHOUT RETURN OF THE DEVICE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    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 FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DUE TO THE PRESENCE OF THE DELIVERY CATHETER SYSTEM (DCS) IN THIS ANATOMY, A DISSECTION OCCURRED IN THE COMMON ILIAC EXTERNAL ARTERY. A STENT WAS PLACED AND NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THERE WAS NO PROBLEM WITH THE SYSTEM AND NO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743773 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-L 0008185276

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention