BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ¿

    MDR report key: 2922694 · Received January 18, 2013

    Report

    Report Number
    2134265-2013-00355
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 24, 2012
    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

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE BALLOON WAS TIGHTLY FOLDED WITH STENT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE STENT WAS NOT RETURNED FOR PRODUCT ANALYSIS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THIS 12X3.00MM LIBERTÉ BARE STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, DURING INSERTION INTO THE CALCIFIED LESION, THE STENT SEPARATED FROM THE BALLOON AND THE PHYSICIAN COULD NOT INSERT THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THIS 12X3.00MM LIBERTÉ BARE STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, DURING INSERTION INTO THE CALCIFIED LESION, THE STENT SEPARATED FROM THE BALLOON AND THE PHYSICIAN COULD NOT INSERT THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28345 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812300 15381633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other