BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VALEO VASCULAR STENT

    MDR report key: 1802553 · Received August 9, 2010

    Report

    Report Number
    2020394-2010-00247
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO STENTS WERE USED DURING THE PROCEDURE AND THE PRODUCT INFO (CATALOG AND LOT NUMBER) FOR BOTH DEVICES WAS PROVIDED BY THE REPORTER. HOWEVER, IT IS UNK WHICH LOT NUMBER IS ASSOCIATED WITH THE REPORTED DEVICE. THE STENT HAS NOT BEEN RETURNED FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K052132.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "KISSING" STENT PROCEDURE, THE PHYSICIAN ADVANCED THE SECOND STENT THROUGH THE FIRST ONE. HOWEVER, THE STENT APPEARED TO PREMATURELY DEPLOYED AND DETACHED FROM THE BALLOON. THE STENT BECAME ENTANGLED IN THE FIRST STENT. THIS RESULTED IN SURGICAL INTERVENTION. ADD'L INFO REGARDING IDENTIFICATION OF THE VESSEL, SURGICAL PROCEDURE AND PT OUTCOME IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VALEO VASCULAR STENT FGE BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention