BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1587906 · Received December 30, 2009

    Report

    Report Number
    2183870-2009-00211
    Event Type
    Other
    Date Received
    December 30, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 4, 2009
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON THE SFA. THE PROTEGE EVERFLEX STENT BECAME HUNG UP IN ANOTHER STENT. THE DISTAL TIP OF THE PROTEGE EVERFLEX DELIVERY SYSTEM BROKE AND THE PHYSICIAN RETRIEVED THE TIP WITH A SPIDER. ANOTHER PROTEGE EVERFLEX WAS DEPLOYED. NO HARM TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3 INC. PRB35-07-080-120 7842492

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 7F TERUMO SHEATH| 6MM SPIDER| IDEV SUPERA STENT