BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2792408 · Received October 16, 2012

    Report

    Report Number
    2134265-2012-06505
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    May 16, 2012
    Report Date
    July 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LIBERTE-VERIFLEX DEVICE WAS RECEIVED WITH A PARTIALLY LOADED PRODUCT MANDREL AND STENT PROTECTOR, WHICH IS PLACED IN FINAL PACKAGING, INDICATING THEY WERE REMOVED AND REPLACED AFTER UNPACKAGING. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS IN A TIGHTLY FOLDED CONDITION INDICATING THERE WAS NO PRESSURE APPLIED. THERE WAS STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE STENT WAS NOT RECEIVED FOR ANALYSIS. THE DISTAL TIP WAS DAMAGED. THE MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY OR THE CONFIRMED STENT DETACHMENT AND TIP DAMAGE. A THOROUGH ANALYSIS OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED CROSSING DIFFICULTY. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DETACHMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STENT WAS LOST DURING THE RETURN PROCESS TO BSC AND DID NOT DISLODGE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893824400 14221091

    Patients

    Seq Age Sex Outcome Treatment
    1