BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTAR STENT SYSTEM

    MDR report key: 3061413 · Received April 10, 2013

    Report

    Report Number
    9681442-2013-00037
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIO
    PMA / PMN Number
    P080007/S014
    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 INCLUDING POUCH COMPONENT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. NO ADDITIONAL COMPLAINT HAS BEEN REPORTED FOR THIS LOT NUMBER. NO MANUFACTURING ANOMALIES OR CHANGES WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN IDENTIFIED. NO SAMPLE HAS BEEN RETURNED AND NO IMAGE HAS BEEN PROVIDED FOR THE PURPOSE OF EVALUATION. THE ALLEGED ISSUE COULD NOT BE REPRODUCED AND THE COMPLAINT WILL BE CLOSED WITH INCONCLUSIVE RESULT. POTENTIAL FACTORS THAT COULD HAVE LED TO THE ALLEGED ISSUE HAVE BEEN EVALUATED. THE REPORTED EVENT MAY BE USE RELATED AS ROUGH HANDLING DURING UNPACKING OF THE DEVICE MAY LEAD TO A PACKAGING DAMAGE. TRANSPORTATION/STORAGE OF THE PRODUCT IS A FURTHER ASPECT THAT HAS TO BE CONSIDERED AS ROOT CAUSE BECAUSE ROUGH HANDLING DURING TRANSPORTATION CAN LEAD TO THE REPORTED DAMAGE. IN THIS CASE A DAMAGE OF THE OUTER BOX WAS NOT REPORTED. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE EVENT REPORTED COULD NOT BE IDENTIFIED. IN REVIEWING THE LABELING SUPPLIED WITH THIS PRODUCT IT WAS FOUND THAT THE INSTRUCTIONS FOR USE (IFU) SUFFICIENTLY ADDRESS THIS POTENTIAL RISK. THE IFU STATES: 'VISUALLY INSPECT THE PACKAGING TO VERIFY THAT THE STERILE BARRIER IS INTACT. DO NOT USE IF THE STERILE BARRIER IS OPEN OR DAMAGED.'

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREPARATION OF THE DEVICE DEMONSTRATED THE INNER PACKAGE WAS NOT COMPLETELY SEALED, A CONCERN FOR STERILITY LOSS. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153222 LIFESTAR STENT SYSTEM NIO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWH0307

    Patients

    Seq Age Sex Outcome Treatment
    1