BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTW COMPLETE SE VASCULAR

    MDR report key: 2830339 · Received November 9, 2012

    Report

    Report Number
    MW5027576
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC INC
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VASCULAR SURGEON, ATTEMPTED TO DEPLOY A MEDTRONIC STENT (8X60) IN THE LEFT EXTERNAL ILIAC FROM A RIGHT COMMON FEMORAL APPROACH, UP AND OVER. THE STENT LOOKED LIKE IT DEPLOYED, BUT IT WAS STUCK TO THE DELIVERY SYSTEM. IN TRYING TO GET THE STENT OFF THE DELIVERY SYSTEM, THE STENT MIGRATED TO THE LEFT COMMON ILIAC, BUT DID NOT GO INTO THE AORTA OR RIGHT COMMON ILIAC. VASCULAR SURGEON HAD TO DEPLOY KISSING I-CAST STENTS, ONE (8X38) INSIDE THE MEDTRONIC STENT IN THE LEFT COMMON ILIAC AND ANOTHER I-CAST (8X59) IN THE RIGHT COMMON ILIAC -KISSING MEANS DEPLOYED AND BALLOONED AT THE SAME TIME-. VASCULAR SURGEON INSERTED TWO 8X4 LIFE STENTS IN THE ORIGINAL AREA OF STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTW COMPLETE SE VASCULAR COMPLETE SE VASCULAR-SELF EXPANDING STENT SYSTEM- 8X60X80 NIO MEDTRONIC INC 0006139811

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention