BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTAR VASCULAR STENT SYSTEM

    MDR report key: 3911607 · Received May 27, 2014

    Report

    Report Number
    9681442-2014-00086
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE OT EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE AND IMAGE WAS PROVIDED. THEREFORE, THE REPORTED EVENT COULD NOT BE REPRODUCED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. INVESTIGATIONS OF SIMILAR COMPLAINT SHAVE BEEN REVIEWED. IN THIS CASE, A DEFECT PTA BALLOON MAY HAVE CAUSE THE REPORTED STENT DISPLACEMENT. AN IRREGULARLY PLACED STENT MIGHT HAVE CONTRIBUTED TO AN ALLEGED ENTRAPMENT OF THE BALLOON DURING POST-DILATION. AN INSUFFICIENT PRE-DILATION, A HIGHLY CALCIFIED VESSEL OF A DIFFICULT VESSEL ANATOMY MAY RESULT IN AN IRREGULAR STENT PLACEMENT. ALSO AN UNINTENDED MOVEMENT OF THE DELIVERY SYSTEM DURING STENT DEPLOYMENT MAY RESULT IN AN IRREGULAR STENT PLACEMENT. IN THIS CASE, ONLY LIMITED PROCEDURAL INFORMATION WAS PROVIDED. THE REPORTED APPLICATION REPRESENTS AN OFF-LABEL USE OF THE DEVICE WHICH AMY BE ANOTHER CONTRIBUTING FACTOR. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE OF THE EVENT REPORTED COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS OBTAINED AFTER FILE CLOSURE; THEREFORE, WAS UPDATED ACCORDINGLY WITH THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VASCULAR STENTING PROCEDURE IN THE CEPHALIC VEIN, DURING POST ANGIOPLASTY THE PTA BALLOON RUPTURED. UPON REMOVAL OF THE RUPTURED BALLOON THE VASCULAR STENT WAS DISPLACED. THEREFORE, AN ADDITIONAL VASCULAR STENT WAS DEPLOYED AT THE LOCATION OF THE DISPLACED STENT. THE CEPHALIC VEIN REPORTED OT BE PATENT WITH GOOD BLOOD FLOW. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311665 LIFESTAR VASCULAR STENT SYSTEM NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXH1385

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention