BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3873651 · Received June 16, 2014

    Report

    Report Number
    2134265-2014-03369
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 22, 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

    (B)(4). DEVICE EVALUATED BY MFR.: THE LIBERTE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED WITH NO OTHER DEVICES. THERE WAS BLOOD IN THE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE STENT WAS SECURE ON THE BALLOON BETWEEN THE MARKERBANDS. MICROSCOPIC EXAMINATION OF THE STENT DID NOT REVEAL ANY DAMAGE OR IRREGULARITIES. THERE WERE MULTIPLE HYPOTUBE KINKS. THE HYPOTUBE WAS COMPLETELY SEPARATED 50CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. 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. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE 1ST DIAGONAL ARTERY. A 2.50MM X 12MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE AND ADVANCED TO THE TARGET LESION BUT WAS UNABLE TO CROSS. IT WAS THEN NOTICED THAT THE STENT STRUTS GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE 1ST DIAGONAL ARTERY. A 2.50MM X 12MM LIBERTE BARE METAL STENT WAS SELECTED FOR USE AND ADVANCED TO THE TARGET LESION BUT WAS UNABLE TO CROSS. IT WAS THEN NOTICED THAT THE STENT STRUTS GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352139 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812250 16444885

    Patients

    Seq Age Sex Outcome Treatment
    1