BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 3021095 · Received March 20, 2013

    Report

    Report Number
    9681442-2013-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NO ADDITIONAL COMPLAINT HAS BEEN PREVIOUSLY REPORTED FOR THIS LOT NUMBER. NO INDICATION WAS FOUND FOR PROCESS OR MANUFACTURING RELATED ISSUES. UPON EVALUATION OF THE RETURNED DEVICE NO ISSUES WERE IDENTIFIED WHICH WOULD INDICATE THAT SUCCESSFUL STENT RELEASE WAS NOT POSSIBLE. THE RESOLUTION OF THE IMAGE PROVIDED WAS POOR AND A LENGTH MEASUREMENT WAS NOT POSSIBLE. . THEREFORE, THE ALLEGED STENT ELONGATION COULD NOT BE REPRODUCED AND THE COMPLAINT WILL BE CLOSED WITH INCONCLUSIVE RESULT. POTENTIAL FACTORS THAT COULD HAVE LED TO THE ELONGATION OF THE STENT HAVE BEEN EVALUATED. A NOT PERFORMED BALLOON PRE-DILATION MAY HAVE BEEN CONTRIBUTING FACTORS TO THE EVENT REPORTED. BASED ON THE INFORMATION AVAILABLE A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATES, "INITIATE STENT DEPLOYMENT BY ROTATING THE THUMBWHEEL IN THE DIRECTION OF THE ARROWS WHILE HOLDING THE HANDLE IN A FIXED POSITION...CONTINUE TURNING THE THUMBWHEEL UNTIL THE DISTAL END OF THE STENT OBTAINS COMPLETE WALL APPOSITION...WHILE MAINTAINING A FIXED HANDLE POSITION FINAL DEPLOYMENT CAN BE CONTINUED WITH FOLLOWING METHODS...THUMBWHEEL...FAST TRACK DEPLOYMENT LEVER...RAPID DEPLOYMENT RING". FURTHERMORE, THE IFU DEMANDS FOR A BALLOON PRE DILATION USING STANDARD TECHNIQUES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VASCULAR STENT IN THE EXTERNAL ILIAC ARTERY, THE VASCULAR STENT BECAME ELONGATED. NO OTHER VASCULAR STENT WAS DEPLOYED TO COVER THE ELONGATION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115569 LIFESTENT VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWJ1082

    Patients

    Seq Age Sex Outcome Treatment
    1