BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 4756914 · Received May 5, 2015

    Report

    Report Number
    9681442-2015-00040
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    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. THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE PARTIAL RELEASE OF THE STENT. THE DEPLOYMENT MECHANISM HAD NOT BEEN USED POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUSLY REPORTED SIMILAR COMPLAINTS HAVE BEEN REVIEWED. A PREMATURE STENT RELEASE DURING PREPARATION CAN BE CAUSED BY INCREASED FRICTION BETWEEN GUIDE WIRE AND GUIDE LUMEN. IN THIS CASE, IT WAS REPORTED THAT RESISTANCE WAS MET. NO DAMAGE TO THE DEVICE PACKAGING WAS REPORTED. THE REPORTED EVENT ALSO MAY BE USE-RELATED AS THE DELIVERY SYSTEM CAN BECOME DAMAGED IF NOT CAREFULLY HANDLED, E. G. BY ROUGH HANDLING DURING PREPARATION WHICH MAY LEAD TO A DEFORMED GUIDE LUMEN. ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENTING PROCEDURE IN THE SFA PRIOR TO PT CONTACT, WHILE BEING LOADED OVER THE GUIDE WIRE RESISTANCE WAS FELT BEFORE THE DELIVERY SYSTEM WAS INSERTED INTO THE SHEATH AND THE STENT WAS DISCOVERED TO BE PARTIALLY DEPLOYED. THE DELIVERY SYSTEM WITH THE VASCULAR STENT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW VASCULAR STENT THAT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293400 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANYJ3359

    Patients

    Seq Age Sex Outcome Treatment
    1