BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT XL

    MDR report key: 2963287 · Received February 11, 2013

    Report

    Report Number
    2963287
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING FEMORAL PTA/STENT PLACEMENT THE SELF EXPANDING STENT MALFUNCTIONED IN THE PATIENTS BODY. THE STENT WOULD NOT DEPLOY DUE TO A FAULTY MECHANISM IN THE HANDLE. THE PHYSICIAN TOOK APPROPRIATE ACTIONS TO CORRECT THE MALFUNCTION. NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59764 LIFESTENT XL STENT, SUPERFICIAL FEMORAL ARTERY NIP BARD PERIPHERAL VASCULAR, INC. * ANVH2127

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR