BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1180941 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02818
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    July 8, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DEVICE ANALYSIS, IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED AND THE TIP OF THE DEVICE WAS DAMAGED. THE STRUTS ON THE FIRST ROW FROM THE DISTAL EDGE WERE RAISED PROXIMALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE DELIVERY SYSTEM ENCOUNTERING SOME FORM OF RESTRICTION. THE TIP WAS DAMAGED DUE TO THE PRODUCT MANDREL. THE DEVICE WAS RETURNED WITH THE PRODUCT MANDREL INSERTED AND THE STENT BALLOON PROTECTOR ATTACHED. ATTEMPTS TO REMOVE THE PRODUCT MANDREL WERE UNSUCCESSFUL DUE TO SOLIDIFIED CONTRAST MEDIA PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN. THE RETURNED DEVICE WAS CONNECTED TO AN ENCORE INFLATION UNIT. THE INFLATION DEVICE WAS PRESSURIZED TO 12 ATM FOR 60 SECONDS, HOWEVER THE BALLOON COULD NOT BE INFLATED DUE TO SOLIDIFIED CONTRAST MEDIA. THE DEVICE WAS SOAKED IN WARM WATER IN ATTEMPTS TO REMOVE THE CONTRAST MEDIA. HOWEVER SUBSEQUENT ATTEMPTS TO INFLATE THE DEVICE PROVED UNSUCCESSFUL. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE MFG DOCUMENTATION SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), THE BALLOON ON THE 3.5X12 MM LIBERTE MONORAIL CORONARY STENT DELIVERY SYSTEM (SDS) DID NOT OPEN EVEN AFTER ATTEMPTING TO INFLATE IT TO 20 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED AND THE TIP OF THE DEVICE WAS DAMAGED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 11273987

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR