BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 793414 · Received December 8, 2006

    Report

    Report Number
    6000093-2006-02555
    Event Type
    Injury
    Date Received
    December 8, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 123 DAYS AFTER IMPLANTATION OF A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT, IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE POSTERIOR ATRIOVENTRICULAR BRANCH ARTERY (PAV). A PRE-INTERVENTION STENOSIS OF 70-90% WAS REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON THE LESION. A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE STENT WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. IT WAS REPORTED THAT THE PT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS WERE REPORTED. THE PT PRESENTED 123 DAYS AFTER THE INITIAL PROCEDURE WITH A 80% IN-STENT RESTENOSIS IN THE PAV. PTCA WAS PERFORMED ON THE LESION. A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE LESION WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 CORP. 2.5X24MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R