BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1905101 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05255
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT WAS RECEIVED FOR ANALYSIS INSIDE A PLASTIC CONTAINER. THE DELIVERY DEVICE WAS NOT RECEIVED FOR ANALYSIS. AN EXAMINATION OF THE STENT FOUND THAT ONE END OF THE STENT WAS PINCHED /COMPRESSED. ONE POSSIBILITY IS THAT THE STENT PROTECTOR WAS GRASPED TOO TIGHTLY DURING WITHDRAWAL FROM THE DELIVERY DEVICE AND AS A RESULT, COMPRESSED AND PULLED THE STENT OFF THE BALLOON. ALSO RECEIVED WAS THE PACKAGING MANDREL AND STENT PROTECTOR. AN EXAMINATION OF THE STENT PROTECTOR FOUND NO ANOMALIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED.WHILE UNPACKING THE 4.50X12MM VERIFLEX STENT DELIVERY SYSTEM (SDS) IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE SDS AND WAS FOUND INSIDE THE PROTECTIVE SHEATH. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. WHILE UNPACKING THE 4.50X12MM VERIFLEX STENT DELIVERY SYSTEM (SDS) IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE SDS AND WAS FOUND INSIDE THE PROTECTIVE SHEATH. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893412450 0013354709

    Patients

    Seq Age Sex Outcome Treatment
    1