BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 2232969 · Received July 22, 2011

    Report

    Report Number
    9681442-2011-00040
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 4, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE LOT RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECS PRIOR TO SHIPMENT. THE SAMPLE WAS RETURNED FOR EVAL. THE SHIPPING LOCK WAS MISSING UPON RECEIPT OF THE SAMPLE AND THE STENT WAS RELEASED AND NOT RETURNED AS IT WAS PLACED IN THE PT. THE DISTAL END OF THE GUIDE WIRE LUMEN WAS FOUND TO BE TORN OFF. ADDITIONALLY, AN INTRODUCER SHEATH AND A BALLOON CATHETER WERE PROVIDED FOR EVAL. THE DETACHED SEGMENT OF GUIDE WIRE LUMEN INCLUDING THE ATRAUMATIC TIP WAS FOUND TO BE STUCK ON THE BALLOON CATHETER PROXIMAL TO THE BALLOON. IT CAN BE CONCLUDED THAT NO SEGMENT OF THE GUIDE WIRE LUMEN IS MISSING. THE CONDITION OF THE SAMPLE IS CONSISTENT WITH THE INFO PROVIDED BY THE CUSTOMER. THE RESULTS OF THE INVESTIGATION ARE CONFIRMED. BASED ON THE INFO AVAILABLE A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. THE CURRENT IFU STATES: IF EXCESSIVE FORCE IS FELT DURING STENT DEPLOYMENT, DO NOT FORCE THE STENT SYSTEM. REMOVE THE STENT SYSTEM AS POSSIBLE, AND REPLACE WITH A NEW UNIT. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA #P070014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING REMOVAL OF THE CATHETER. REPORTEDLY, THE DISTAL TIP OF THE DELIVERY SYSTEM DETACHED FROM THE DELIVERY SYSTEM. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVC2818

    Patients

    Seq Age Sex Outcome Treatment
    1