BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080405 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02037
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    February 12, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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 COMPLAINT 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

    TAXUS EXPRESS2 CLINICAL STUDY. SAME CASE AS 2134265-2008-02036, 2134265-2008-02029. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PROXIMAL LAD WAS 3.5MM, 24MM LONG. THE PHYSICIAN PLACED A 3.5X24MM TAXUS EXPRESS2 STUDY STENT IN THE PROX LAD. THE PHYSICIAN PLACED A 3.0X32MM TAXUS EXPRESS2 STUDY STENT IN THE MID LAD. THEN THE PHYSICIAN PLACED A 2.75X16MM TAXUS EXPRESS2 STUDY STENT AT D2 LAD. POST DILATATION WAS PERFORMED USING A 2.5-12. A DISSECTION OCCURRED IN THE PROX LAD AND OCCLUSION WAS CONFIRMED AT D2. IT IS UNK WHICH STENT CAUSED THE DISSECTION. THE PHYSICIAN THEN IMPLANTED A STENT FROM LMT TO LAD PROXIMAL FOR DISSECTION AND NEEDED THE RECANALIZATION. AFTER IMPLANTATION OF THE STENTS IVUS WAS PERFORMED AND THERE WAS NO ADD'L COMPLICATIONS. TWO NON BSC STENT WERE IMPLANTED AT LMT AND THE PROX LCX. THE PHYSICIAN SAID, THIS EVENT WAS RELATED TO THE TAXUS STENT. THE PT WAS DISCHARGED FROM THE HOSPITAL ON PLAVIX AND ASPIRIN. ADD'L INFO HAS BEEN REQUESTED, BUT HAVE BEEN UNSUCCESSFUL.

    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 2.75X16MM 9496304

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R