BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 3050272 · Received April 10, 2013

    Report

    Report Number
    2183870-2013-00091
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EV3 INC.
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SFA ATHERECTOMY AND STENTING. AFTER ATHERECTOMY, THE VESSEL WAS STILL NOT COMPLETELY OPEN. THE PHYSICIAN PLACED THE PROTEGE EVERFLEX STENT IN THE SFA. UPON REMOVAL OF THE CATHETER IT WAS NOTED THAT PART OF THE CATHETER HAD BROKEN OFF AND WAS STILL IN THE BODY. A SNARE WAS USED TO RETRIEVE THE CATHETER PIECE AND THE PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148249 EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP EV3 INC. PRB35-07-150-120 9696576

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention GLIDEWIRE| 7F DESTINATION SHEATH