BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3890158 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03574
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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.: RETURNED PRODUCT CONSISTED OF A LIBERTE STENT DELIVERY SYSTEM (SDS) WITH STENT AND NO OTHER DEVICES. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. MAGNIFIED AND VISUAL INSPECTION CONFIRMED THERE WAS NO DAMAGE TO THE STENT. THERE WAS A COMPLETE HYPOTUBE SEPARATION 17CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OR THE REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING PREDILATION WITH A 1.5X20MM UNSPECIFIED BALLOON CATHETER, A 2.50MM X 8MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION. HOWEVER, DURING THE PROCEDURE, "THE STENT HAS NOT PASSED" AND WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING PREDILATION WITH A 1.5X20MM UNSPECIFIED BALLOON CATHETER, A 2.50MM X 8MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION. HOWEVER, DURING THE PROCEDURE, "THE STENT HAS NOT PASSED" AND WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368165 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H749389388250 16489006

    Patients

    Seq Age Sex Outcome Treatment
    1