BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 781150 · Received November 9, 2006

    Report

    Report Number
    6000093-2006-02287
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    October 9, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 8161025 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

    IT WAS REPORTED THAT 199 DAYS AFTER IMPLANTATION OF A 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE PROXIMAL 1ST DIAGONAL ARTERY (D1). A PRE-INTERVENTION STENOSIS WAS NOT REPORTED. THE LESION WAS PRE-DILATED WITH A 2.0X8MM MAVERICK BALLOON. A 3.0X12MM TAXUS STENT WAS DEPLOYED AT 18 ATM IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE STENT WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PATIENT RECEIVED HEPARIN AND PLAVIX DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL. COMPLICATIONS WERE REPORTED AS "NONE." THE PATIENT PRESENTED 199 DAYS AFTER THE INITIAL PROCEDURE WITH RECURRENT ANGINA. CORONARY ANGIOGRAPHY REVEALED A 100%IN-STENT RESTENOSIS IN THE 1ST DIAGONAL ARTERY. "NO RE-INTERVENTION WAS PERFORMED." THE PATIENT WAS MANAGED MEDICALLY. PRIOR TO ANGIOGRAPHY, THE PATIENT WAS PREMEDICATED WITH ASPIRIN, PLAVIX, BENADRYL, PREDNISONE, AND ZANTAC. DURING ANGIOGRAPHY THE PATIENT RECEIVED INTRACORONARY NITROGLYCERIN. THE PATIENT "TOLERATED THE PROCEDURE WELL AND THERE WERE NO APPARENT 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 3.0X12MM 8161025

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R