BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1318161 · Received February 23, 2009

    Report

    Report Number
    2134265-2008-03359
    Event Type
    Injury
    Date Received
    February 23, 2009
    Date of Event
    September 11, 2006
    Report Date
    September 14, 2006
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS RETURNED WITHOUT THE CRIMPED STENT. SEVERAL SEVERE KINKS WERE FOUND ALONG THE HYPOTUBE. THIS TYPE OF DAMAGE TO THE HYPOTUBE IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. A REVIEW OF THE MANUFACTURING RECORD FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS UNKNOWN. BSC ID #A00036469 TW#222175

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING TREATMENT PROCEDURE, THE STENT DISLODGED INSIDE THE PATIENT. THE HEAVILY CALCIFIED TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X24MM TAXUS LIBERTE DRUG ELUTING STENT (DES) HAD BEEN SELECTED AND ADVANCED TO TREAT THE TARGET LESION. AFTER "SEVERAL" ATTEMPTS TO DEPLOY THE STENT, THE STENT DISLODGED AND MIGRATED TO THE DISTAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS SATISFACTORY AND GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC IRELAND LTD. 3.0X24MM 8647079

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other