BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2022613 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00818
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT RADIAL ARTERY. THE 90% STENOTIC, DE NOVO LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH AN UNSPECIFIED BALLOON AND THEN ADVANCED THE 2.75X38MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. UPON REMOVAL IT WAS OBSERVED THAT THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A POBA. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638270 13823304

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR