BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 3912497 · Received May 14, 2014

    Report

    Report Number
    9681442-2014-00080
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NOT LOT NUMBER AND NO PRODUCT CATALOG NUMBER WAS PROVIDED. 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. TWO DIGITAL PHOTOS WERE PROVIDED WHICH CONFIRM A TWISTING OF THE STENT PLACED MORE DISTALLY IN THE SFA LEADING TO A CONSTRICTION OF THE STENT LUMEN. NO FRACTURE OF THIS STENT COULD BE IDENTIFIED. 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 USE-RELATED AND ANATOMICAL FACTORS WITH THE GIVEN STENT DESIGN. ALSO VARIOUS PHYSICAL FORCES INCLUDING INDIVIDUAL PATIENT FACTORS MAY CONTRIBUTE TO THE TWISTING OF A STENT IN THIS REGION. ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY ADDRESSES THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST IMPLANTATION OF TWO VASCULAR STENTS IN THE SFA, MULTIPLE FRACTURES AND AN OCCLUSION WERE DISCOVERED. THIS RECORD ADDRESSES THE REPORTED ISSUE WITH THE STENT PLACED MORE DISTALLY IN THE SFA. PATIENT INDICATORS WILL DETERMINE IF AN ADDITIONAL VASCULAR PROCEDURE NEEDS TO BE PERFORMED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287883 LIFESTENT VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR