BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3122373 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03238
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH THE ORIGINAL SHELF BOX AND INNER POUCH. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED AND THE STENT WAS SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THE HYPOTUBE WAS SEPARATED 20.5 CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE DISTAL TIP WAS DAMAGED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE COMPLAINT EVENT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 18X3MM, CONCENTRIC, DE NOVO, 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PREDILATION OF THE LESION WITH NON-BSC 2.5X20MM, 3X14MM AND 3X20MM BALLOONS, THE PHYSICIAN BEGAN TO ADVANCE A 3.00X20MM LIBERTE STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. HOWEVER, THE SDS FRACTURED DURING INTRODUCTION. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE A SHAFT FRACTURE OCCURRED. THE 18X3MM, CONCENTRIC, DE NOVO, 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PREDILATION OF THE LESION WITH NON-BSC 2.5X20MM, 3X14MM AND 3X20MM BALLOONS, THE PHYSICIAN BEGAN TO ADVANCE A 3.00X20MM LIBERTE STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. HOWEVER, THE SDS FRACTURED DURING INTRODUCTION. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224331 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820300 15360896

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR