BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 762912 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02035
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    August 20, 2006
    Report Date
    August 22, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE NO ANALYSIS COULD BE PERFORMED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8233654 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT EMBOLIZATION OCCURRED. THE LESION WAS LOCATED IN THE POSTERIOR DESCENDING ARTERY (PDA). THE VASCULAR ACCESS SITE WAS THE LEFT FEMORAL ARTERY (LFA). THE VESSEL SIZE WAS 2.50MM IN DIAMETER AND 80% STENOSED. THE LESION WAS SUCCESFULLY CROSSED WITH A GUIDEWIRE AND THEN PREDILATED WITH A 2.00X20.0MM BALLOON. WHILE INTRODUCING A TAXUS LIBERTE 2.50X24.0MM DRUG ELUTING STENT (DES) THROUGH THE WIRE THE STENT WOULDN'T CROSS THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO SIGNIFICANT "ASTHENTRIC" LESION OR CALCIFICATION PRESENT IN THE PROXIMAL RCA. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) THE STENT SLIPPED FROM ITS BALLOON INSIDE THE PROXIMAL RCA. THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE STENT AND IT REMAINS IN THE PATIENT. THE PATIENT IS STABLE AND THERE ARE NO REPORTED PATIENT COMPLICATIONS. PLAVIX, UNSPECIFIED BETA BLOCKERS, AND AN UNSPECIFIED STATIN WERE ADMINISTERED TO THE PATIENT PRIOR TO THE PROCEDURE. DURING THE PROCEDURE THE PATIENT RECEIVED HEPARIN. FOLLOWING THE PROCEDURE THE PATIENT RECEIVED BETA BLOCKERS, STATINS AND ASA. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X24.0MM 8233654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R UNK.