BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2

    MDR report key: 791530 · Received December 5, 2006

    Report

    Report Number
    6000093-2006-02511
    Event Type
    Injury
    Date Received
    December 5, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-6: THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8200925 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORM.

    Description of Event or Problem · 1

    TAP. IT WAS REPORTED THAT 224 DAYS AFTER IMPLANTATION OF A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT, IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE POSTERIOR DESCENDING BRANCH ARTERY (PDA). A PRE-INTERVENTION STENOSIS OF 80% WAS REPORTED. THE LESION WAS PREDILATED WITH A 2.0X15MM MAVERICK BALLOON. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT 14 ATM IN THE PDA 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 PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS WERE REPORTED. THE PATIENT PRESENTED 224 DAYS AFTER THE INITIAL PROCEDURE WITH A 99% IN-STENT RESTENOSIS WITH TIMI GRADE II FLOW IN THE PDA. ANGIOPLASTY WAS PERFORMED ON THE LESION USING A 2.0X10MM CUTTING BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI GRADE III FLOW WAS REPORTED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PATIENT RECEIVED HEPARIN DURING THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 NIQ: STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC 2.5X20MM 8200925

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R 0.14 CHOICE FLOPPY GUIDEWIRE.