BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3760983 · Received April 9, 2014

    Report

    Report Number
    9681442-2014-00062
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER OF THE SUBJECT DEVICE HAS NOT BEEN PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE WAS RETURNED. ON THE BASIS OF THE IMAGE PROVIDED, IT CAN BE CONFIRMED THAT THE STENT WAS TWISTED, HOWEVER, AN OCCLUSION COULD NOT BE CONFIRMED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE TWISTING OF THIS KIND OF STENT MAY BE CAUSED BY INTERACTIONS OF VARIOUS US-RELATED AND ANATOMICAL FACTORS WITH THE GIVEN STENT DESIGN. THERE ARE ALSO VARIOUS PHYSICAL FORCES INCLUDING INDIVIDUAL PATIENT FACTORS THAT MAY CONTRIBUTE TO THE TWISTING OF A STENT IN THIS REGION. IN THIS CASE, THE VESSEL WAS REPORTED TO BE CALCIFIED. O THE BASIS OF THE INFO AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANTATION OF A VASCULAR STENT, GUIDED FLUOROSCOPY DEMONSTRATED A TWISTING OF THE STENT CAUSING THE SFA TO RE-OCCLUDE. AN ANGIOPLASTY WAS PERFORMED AND TWO NEW VASCULAR STENTS WERE IMPLANTED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213242 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention