BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1423587 · Received April 20, 2009

    Report

    Report Number
    9681442-2009-00042
    Event Type
    Malfunction
    Date Received
    April 20, 2009
    Date of Event
    March 23, 2009
    Report Date
    March 26, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A DEVICE PMA #P070014, CURRENTLY DISTRIBUTED IN THE U.S. THE REVIEW OF THE MFG RECORDS SHOWED THAT NO REMARKABLE INCIDENTS OCCURRED. THE SAMPLE WAS RETURNED TO THE MFG SITE AND THE EVAL IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT IN THE SHEATH, THE CATHETER TIP BROKE OFF. THIS WAS NOTICED DURING STENT DEPLOYMENT. THERE WAS NO REPORT OF INJURY TO THE PT. ADDITIONAL EVENT INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK 58554008

    Patients

    Seq Age Sex Outcome Treatment
    1