BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3871268 · Received April 16, 2014

    Report

    Report Number
    9681442-2014-00064
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF THE VASCULAR STENT IN A HIGHLY CALCIFIED SFA, THE STENT BROKE OFF IN THE PATIENT. NO PRE-DILATION HAD BEEN PERFORMED. THE PROCEDURE WAS COMPLETED BY THE PLACEMENT OF ANOTHER VASCULAR STENT INSIDE AND DISTALLY TO THE FRAGMENTED STENT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233656 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXL0845

    Patients

    Seq Age Sex Outcome Treatment
    1