BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3971243 · Received June 30, 2014

    Report

    Report Number
    9681442-2014-00099
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. BASED ON THE EVALUATION OF THE RETURNED SAMPLE, IT CAN BE CONFIRMED THAT THE DEPLOYMENT MECHANISM HAD BEEN USED UNTIL THE BREAKAGE OF A FORCE TRANSMITTING JOINT OCCURRED. FURTHER USE LED TO THE EXPOSURE OF INNER COMPONENTS, BLOCKAGE OF THE RELEASE MECHANISM AND FRACTURE OF A FORCE TRANSMITTING COMPONENT. THE STENT WAS FOUND TO BE FRACTURED WHICH MUST HAVE OCCURRED DURING THE ATTEMPT TO REMOVE THE DELIVERY SYSTEM WITH THE STENT. THE CONDITION OF THE SAMPLE INDICATED THAT INCREASED RELEASE FORCE WAS PRESENT WHICH IS CONSIDERED THE REASON FOR THE FRACTURE OF A FORCE TRANSMITTING JOINT AND SUBSEQUENT DEPLOYMENT FAILURE. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE EVENT MAY BE RELATED TO A DIFFICULT ANATOMY AS HIGHLY TORTUROUS AND CALCIFIED VESSELS MAY LEAD TO INCREASED FRICTION AND SUBSEQUENT RELEASE FORCE INCREASE. THE EVENT ALSO MAY BE USE-RELATED AS ROUGH HANDLING OR INSUFFICIENT FLUSHING OF THE DEVICE MAY LEAD TO THE EVENT REPORTED. THE USE OF A 0.018" GUIDE WIRE ALSO MAY BE A CONTRIBUTING FACTOR. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT, THE VASCULAR STENT WAS PARTIALLY DEPLOYED WHEN IT FRACTURED OFF FROM THE DEPLOYMENT SYSTEM. THE DELIVERY SYSTEM WITH THE REMAINING PART OF THE STENT WAS EXCHANGED FOR ANOTHER VASCULAR STENT THAT WAS DEPLOYED SUCCESSFULLY. AN ADDITIONAL VASCULAR STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378690 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXH3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention