BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 734359 · Received July 10, 2006

    Report

    Report Number
    6000093-2006-01268
    Event Type
    Injury
    Date Received
    July 10, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 7896019 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 208 DAYS AFTER IMPLANTATION OF A 3.0X20 MM TAXUS EXPRESS2 DRUG ELUTING ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, A 99 % STENOTIC LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). NO INFORMATION WAS REPORTED ON LESION CALCIFICATION OR VESSEL TORTUOSITY. AFTER PRE-DILATION WITH A MAVERICK 2.5X20 MM BALLOON, A 3.0X20 MM TAXUS STENT WERE DEPLOYED IN THE LESION AT 16 ATMS FOLLOWED BY POST-DILATION WITH A QUANTUM MAVERICK 3.5X20 MM BALLOON. AN ADDITIONAL 2.75X20 MM TAXUS STENT WAS DEPLOYED DISTAL TO THE 3.0X20 MM TAXUS STENT. POST-INTERVENTION ANGIOGRAM RESULTS WERE REPORTED AS "GOOD RESULTS." THE PATIENT RECEIVED NITROGLYCERIN AND ANGIOMAX DURING THE PROCEDURE AND WAS PLACED ON PLAVIX AND ASPIRIN POST-PROCEDURE. THE PATIENT WAS REPORTED TO HAVE SUFFERED FACIAL HIVES POST PROCEDURE WHICH WERE TREATED MEDICALLY. HE OTHERWISE TOLERATED THE PROCEDURE WELL. THE PATIENT PRESENTED 208 DAYS AFTER THE INITIAL PROCEDURE WITH A 90-95% IN-STENT RESTENOSIS IN THE MID LAD. THE LESION WAS TREATED WITH A ROTABLATOR AND BALLOON DILATION FOLLOWED BY A BRACHYTERAPY. A POST-INVERVENTION STENOSIS OF 0% AND A TIMI GRADE III FLOW WERE REPORTED. NO INFORMATION WAS REPORTED CONCERNING PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.00X20MM 7896019

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O