BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 775734 · Received October 31, 2006

    Report

    Report Number
    6000089-2006-02351
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    September 19, 2006
    Report Date
    October 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW; THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MFG RECORDS FOR THIS PARTICULAR BATCH #8210342 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF RELEASE TO DIST.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S SPOUSE THAT, 98 DAYS FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED ANEMIA. A 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. THE PT'S SPOUSE REPORTED THAT 98 DAYS LATER, THE PT EXPERIENCED "SEVERE ANEMIA WITH A HEMOGLOBIN OF 5.8 THAT CAUSED HIM TO HAVE TO STAY IN THE ICU". THE SPOUSE REPORTED THAT THE PT WAS TAKING COUMADIN, ASPIRIN AND PLAVIX, WHICH WERE DISCONTINUED UPON HOSP ADMISSION IN SEPT 2006. THE PT WAS THEN RE-STARTED ON PLAVIX AND COUMADIN, BUT NOT ASPIRIN. A RECENT COMPLETE BLOOD COUNT WAS "NORMAL". F/U WITH THE PT'S PHYSICIAN WAS DONE; HOWEVER, THE PHYSICIAN REPORTED THAT HE CANNOT DISCUSS INFO REGARDING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.0X12MM 8210342

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other