BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 774294 · Received October 26, 2006

    Report

    Report Number
    6000089-2006-02316
    Event Type
    Injury
    Date Received
    October 26, 2006
    Date of Event
    September 29, 2006
    Report Date
    September 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 #8202888 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TAP - IT WAS REPORTED THAT 209 DAYS AFTER IMPLANTATION OF A 3.0X28MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION STENOSIS WAS NOT REPORTED. THE LESION WAS PRE-DILATED WITH A 2.5X12MM MAVERICK BALLOON. A 3.0X28MM TAXUS STENT WAS DEPLOYED AT 14 ATM IN THE REGION OF THE LESION. IT WAS REPORTED THAT THE STENT WAS NOT POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE LESION WAS REPORTED TO BE NONCALCIFIED AND THE VESSEL NONTORTUOUS. THE PT REC'D LOVENOX PRIOR; INTEGRILIN AND HEPARIN DURING; PLAVIX AND ASPIRIN AFTER THE PROCEDURE. THE PT TOLERATED THE PROCEDURE WELL. THE PT PRESENTED 209 DAYS AFTER THE INITIAL PROCEDURE WITH CHEST PAIN AND A 90% IN-STENT RESTENOSIS. THE LESION WAS PREDILATED WITH A 3.0X15MM QUANTUM MAVERICK BALLOON. AN ATHERECTOMY WAS PERFORMED USING A CUTTING BALLOON. A 2.5X8MM TAXUS STENT WAS DEPLOYED AT 8 ATM IN THE REGION OF THE LESION. THE STENT WAS POST-DILATED WITH A 3.0X8MM QUANTUM BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI GRADE III FLOW WAS REPORTED. THE PT REC'D ANGIOMAX, AND NITROGLYCERIN DURING THE PROCEDURE. THE PT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.0X28MM 8202888

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R