BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM

    MDR report key: 6050151 · Received October 24, 2016

    Report

    Report Number
    9681442-2016-00273
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    UDI-DI
    04049519001296
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. DURING THE EVALUATION OF THE RETURNED DELIVERY SYSTEM, THE STENT WAS FOUND PARTIALLY DEPLOYED WITH THE SHIPPING LOCK BEING ATTACHED TO THE SYSTEM. NONE OF THE DIFFERENT DEPLOYMENT MODES WAS FOUND TO HAVE BEEN ACTIVATED. DURING THE PERFORMED FUNCTION TEST, THE STENT COULD BE RELEASED WITHOUT ANY ISSUES. FOR THIS REASON, THE REPORTED DEPLOYMENT FAILURE COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THE PREMATURE STENT DEPLOYMENT MAY BE ASSOCIATED WITH ROUGH HANDLING OF THE DELIVERY SYSTEM DURING ADVANCEMENT TO THE LESION SITE OR DUE TO RESISTANCE BETWEEN THE GUIDE WIRE LUMEN AND THE GUIDE WIRE, OR BETWEEN THE INTRODUCER SHEATH AND THE DEPLOYMENT SYSTEM. THE REPORTED EVENT ALSO MAY BE RELATED TO A DIFFICULT VESSEL ANATOMY LEADING TO INCREASED FRICTION AND SUBSEQUENT PREMATURE STENT DEPLOYMENT. IN THIS CASE, THE TRACKING PATH WAS REPORTED TO BE CALCIFIED; HOWEVER, NO DIFFICULTIES IN ADVANCING THE SYSTEM TO THE LESION SITE WERE REPORTED. REPORTEDLY, THE LESION HAD BEEN PRE-DILATED. ON THE BASIS OF THE INFORMATION AVAILABLE AND THE EVALUATION OF THE RETURNED SAMPLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU STATES: "VISUALLY INSPECT THE DISTAL END OF THE STENT SYSTEM TO ENSURE THAT THE STENT IS CONTAINED WITHIN THE SHEATH. DO NOT USE IF THE STENT IS PARTIALLY DEPLOYED." AND "IF RESISTANCE IS MET DURING STENT SYSTEM INTRODUCTION, THE STENT SYSTEM SHOULD BE REMOVED AND ANOTHER STENT SYSTEM SHOULD BE USED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING OF A PRE-DILATED LESION IN THE SFA VIA COMMON FEMORAL ARTERY ACCESS, THE STENT COULD NOT BE DEPLOYED. REPORTEDLY, THE TRACKING ANATOMY WAS CALCIFIED AND NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STENTING OF A PRE-DILATED LESION IN THE SFA VIA COMMON FEMORAL ARTERY ACCESS, THE STENT COULD NOT BE DEPLOYED. REPORTEDLY, THE TRACKING ANATOMY WAS CALCIFIED AND NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703431 LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM VASCULAR AND BILIARY STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANAR2079 04049519001296

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR