BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 3609012 · Received January 28, 2014

    Report

    Report Number
    9681442-2014-00017
    Event Type
    Injury
    Date Received
    January 28, 2014
    Date of Event
    December 31, 2013
    Report Date
    December 31, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # P070014. 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 THREE MONTHS POST SUCCESSFUL IMPLANTATION OF A VASCULAR STENT IN THE SFA, THE PT FELT PAIN IN HIS LEG. ANGIOGRAPHY SHOWED THAT THE STENT WAS DISLOCATED. A THROMBOLYTIC TREATMENT WAS PERFORMED AND A FURTHER RE-VASCULARIZATION PROCEDURE WILL BE NECESSARY TO TREAT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60281 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXD1820

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention