BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080397 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02031
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE MFR REPORT #: 2134265-2008-02032, 2033. TAXUS EXPRESS2 POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT 195 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED FOUR TARGET LESIONS. TARGET LESION ONE WAS A DE NOVO, 75% STENOSED, 2.9X9.5MM LESION OF THE PROXIMAL RCA (RIGHT CORONARY ARTERY). TARGET LESION ONE WAS TREATED WITH DIRECT STENTING USING A 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STENT RESULTING IN A WELL POSITIONED, WELL APPOSED STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION TWO WAS A DE NOVO, 100% STENOSED, 3.0X34MM LESION OF THE MID RCA. TARGET LESION TWO WAS TREATED WITH PREDILATION USING AN UNK MANUFACTURER'S 2.5X20MM BALLOON CATHETER, WHICH RESULTED IN A "MILD" DISSECTION. TARGET LESION TWO AS FURTHER TREATED WITH OVERLAPPING 2.5X20MM AND 3.0X20MM TAXUS EXPRESS2 DRUG ELUTING STENTS RESULTING IN WELL POSITIONED, WELL APPOSED STENTS WITH 0% RESIDUAL STENOSIS. TARGET LESION THREE WAS A DE NOVO, 90% STENOSED, 3.3X9MM LESION OF THE OSTIAL PROXIMAL LAD (LEFT ANTERIOR DESCENDING). TARGET LESION THREE WAS TREATED WITH DIRECT STENTING USING A 3.5X12MM TAXUS EXPRESS2 DRUG ELUTING STENT RESULTING IN A WELL POSITIONED, WELL APPOSED STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION FOUR WAS A DE NOVO, 90% STENOSED, 2.7X15.9MM LESION OF THE OSTIAL MID LAD. TARGET LESION FOUR WAS TREATED WITH DIRECT STENTING USING A 3.0X24MM TAXUS EXPRESS2 DRUG ELUTING STENT AND POST DILATION RESULTING IN A WELL POSITIONED, WELL APPOSED STENT WITH 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED THE FOLLOWING DAY ON ASA AND PLAVIX. THE PT WAS READMITTED TO THE HOSPITAL 194 DAYS FOLLOWING THE INDEX PROCEDURE. ON DAY 195, THE PHYSICIAN CONFIRMED A 100% OCCLUSION OF THE PROXIMAL RCA AND A 90% IN-STENT RESTENOSIS OF THE DISTAL RCA. ON DAY 196, THE PROXIMAL RCA OCCLUSION WAS TREATED WITH AN UNK SIZE TAXUS EXPRESS2 DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS AND THE DISTAL RCA IN-STENT RESTENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 25% RESIDUAL STENOSIS. THE EVENT WAS REPORTED TO BE RESOLVED, AND THE PT WAS DISCHARGED ON ASA AND PLAVIX ON DAY 197. THE PHYSICIAN ASSESSED BOTH EVENTS AS DEFINITELY RELATED TO THE TAXUS EXPRESS2 DRUG ELUTING STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ-STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.0X16MM 9644622

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R