BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

    MDR report key: 730470 · Received June 26, 2006

    Report

    Report Number
    6000093-2006-01171
    Event Type
    Injury
    Date Received
    June 26, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ARRIVE2 CLINICAL REGISTRY #125-092 GAH. IT WAS REPORTED THAT 371 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A RE-INTERVENTION WAS PERFORMED ON THE TARGET LESION. THE INDEX PROCEDURE IDENTIFIED AND TREATED ONE TARGET LEISON. THE LESION WAS AN 80% STENOSED, MODERATELY CALCIFIED, MILDLY TORTUOUS, IN-STENT RESTENOTIC LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY (PDA). THE LESION WAS 3MM IN LENGTH AND 2.5MM IN DIAMETER. THE PHYSICIAN DID NOT PRE-DILATE THE LESION. A TAXUS EXPRESS2 2.50 X 12MM STENT WAS DEPLOYED AT 9 ATMS. THE STENT OVERLAPPED TWO PREVIOUSLY PLACED STENTS, ONE BARE METAL AND ONE DRUG ELUTING BY 5MM. THE PHYSICIAN POST DILATED THE STENT AT 14 ATMS. THE RESULTS WERE 0% RESIDUAL STENOSIS WITH TIMI-3 FLOW. THE PT WAS DISCHARGED THE FOLLOWING DAY ON PLAVIX AND ASPIRIN. THE SITE REPORTED THAT THE PT WAS ADMITTED TO THE HOSP 369 DAYS FOLLOWING THE INDEX PROCEDURE. THE PT WAS TAKING PLAVIX AND ASPIRIN. TWO DAYS LATER, THE PT UNDERWENT A TARGET VESSEL RE-INTERVENTION. THE PHYSICIAN USED PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO REDUCE THE STENOSIS. THE PT WAS DISCHARGED THE FOLLOWING DAY ON PLAVIX AND ASPISIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.50 X 12MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R