BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3844960 · Received June 3, 2014

    Report

    Report Number
    2134265-2014-02984
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 7, 2014
    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

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A LIBERTE STENT DELIVERY SYSTEM (SDS) AND STENT WITH A LIBERTE SHELF BOX, CARRIER TUBE (HOOP), AND PRODUCT MANDREL. THE PRODUCT MANDREL WAS IN THE GUIDEWIRE LUMEN OF THE LIBERTE DEVICE; AS RECEIVED. THE BATCH NUMBER ON THE RETURNED PACKAGING AND DEVICE MATCHED THE COMPLAINT BATCH NUMBER. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURE ON THE BALLOON. THE PRODUCT MANDREL WAS PROTRUDING 11CM FROM THE DISTAL TIP OF THE LIBERTE DEVICE. THERE WAS A COMPLETE MIDSHAFT SEPARATION AT THE EXIT NOTCH. THE MIDSHAFT WAS STRETCHED 12MM PROXIMAL OF THE EXIT NOTCH. THE DISTAL SHAFT AND TIP WERE STRETCHED AND BUCKLED FOR 7MM. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. AN ATTEMPT WAS MADE TO SEPARATE THE PRODUCT MANDREL FROM THE DEVICE BUT WAS UNSUCCESSFUL DUE TO THE SHAFT AND TIP DAMAGE. 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

    REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT A DIFFICULTY CROSSING EVENT OCCURRED. A 2.50MM X 8MM LIBERTÉ STENT DELIVERY SYSTEM WAS SELECTED TO TREAT THE LESION. THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323943 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H749389388250 15972515

    Patients

    Seq Age Sex Outcome Treatment
    1