BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 3061901 · Received April 16, 2013

    Report

    Report Number
    2183870-2013-00097
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS A LEFT ARM FISTULA STENTING. THE PROTEGE EVERFLEX STENT DID NOT COMPLETELY EXPAND AFTER PREDILATION. AFTER DEPLOYMENT, THE TIP OF THE DELIVERY SYSTEM WAS NOTICED FLOATING PROXIMALLY IN THE ARM. THERE WAS NO RESISTANCE FELT DURING DEPLOYMENT OR PULLING BACK ON THE DEVICE. A SECOND STENT WAS USED TO PIN THE TIP UP ON THE WALL OF THE VESSEL. A THIRD STENT WAS USED TO STENT THE ORIGINAL STENT THAT WAS NOT FULLY EXPANDED. A WALL STENT WAS USED TO EXPAND THE PROTÉGÉ EVERFLEX. NO ADDITIONAL COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162856 EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP EV3 INC. PRB35-08-080-080 9660854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention