BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 3871199 · Received April 16, 2014

    Report

    Report Number
    9681442-2014-00066
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. 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 AND NO IMAGES WERE PROVIDED FOR EVAL. THEREFORE, THE REPORTED PROBLEM COULD NOT BE REPRODUCED. POTENTIAL FACTORS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE EVENT MAY BE ASSOCIATED WITH DIFFICULT ANATOMIC CONDITIONS WHICH MAY HAVE LED TO INCREASED FRICTION DURING STENT DEPLOYMENT. ALSO, ROUGH HANDLING OF THE DEVICE DURING UNPACKAGING OR USE COULD BE A CONTRIBUTING FACTOR. BASED ON THE INFO AVAILABLE AND AS NO SAMPLE WAS RETURNED, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VASCULAR STENT, THE DEPLOYMENT MECHANISM BECAME BLOCKED WHILE THE STENT WAS PARTIALLY RELEASED AND ADD'L MANIPULATION WAS NEEDED TO COMPLETE THE STENT PLACEMENT SUCCESSFULLY. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233823 LIFESTENT VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXG2455

    Patients

    Seq Age Sex Outcome Treatment
    1