BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ?

    MDR report key: 3943420 · Received July 18, 2014

    Report

    Report Number
    2134265-2014-04197
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A LIBERTE SDS WITH STENT. THERE WAS CONTRAST IN THE INFLATION LUMEN AND THE HYPOTUBE AS WELL AS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BALLOON MATERIAL OR THE TIP. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE AND SHAFT OF THE DEVICE. THE HYPOTUBE WAS FRACTURED 21.5CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. 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 SHAFT BREAK OCCURRED. A 3.00MM X 12MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT THE UNSPECIFIED TARGET VESSEL. WHILE THE PHYSICIAN WAS TRYING TO PASS THE LESION, IT WAS NOTICED THAT THE STENT¿S PROXIMAL SHAFT HAS BEEN BROKEN. THE DEVICE WAS THEN RETRIEVED WITH A SNARE. 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 SHAFT BREAK OCCURRED. A 3.00MM X 12MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT THE UNSPECIFIED TARGET VESSEL. WHILE THE PHYSICIAN WAS TRYING TO PASS THE LESION, IT WAS NOTICED THAT THE STENT¿S PROXIMAL SHAF THAS BEEN BROKEN. THE DEVICE WAS THEN RETRIEVED WITH A SNARE. 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
    422965 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812300 16535550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention