BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL STENT DELIVERY SYSTEM

    MDR report key: 729837 · Received June 26, 2006

    Report

    Report Number
    6000093-2006-01184
    Event Type
    Injury
    Date Received
    June 26, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE DELIVERY DEVICE HAS BEEN DISPOSED, THEREFORE NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE MANUFACTURING RECORS FOR TOP ASSEMBLY BATCH 8193510 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENT PROCEDURE, THE STENT DISLODGED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. THE PHYSICIAN DID NOT FEEL THE LIBERTE' MONORAIL STENT WAS POSITIONED CORRECTLY IN THE CIRCUMFLEX; THE LIBERTE' MONORAIL STENT DELIVERY SYSTEM WAS REMOVED, AND IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY DEVICE. THE STENT WAS LOCATED UNDER FLUOROSCOPY IN THE PROXIMAL CIRCUMFLEX STICKING INTO THE LEFT MAIN. THE PHYSICIAN TRIED, UNSUCCESSFULLY, TO RETRIEVE THE DISLODGED STENT WITH A SNARE. A 5.0X28MM LIBERTE' MONORAIL STENT WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. IT WAS FURTHER REPORTED THAT THE TIP OF ANOTHER MANUFACTURE'S WIRE "FELL OFF" AFTER THIS DISLODGEMENT. PATIENT STATUS IS LIESTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL STENT DELIVERY SYSTEM CORONARY STENT WITH DELIVERY SYSTEM MAF BOSTON SCIENTIFIC 28X4.50MM 8193510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention