BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 770989 · Received October 17, 2006

    Report

    Report Number
    6000089-2006-02262
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    September 17, 2006
    Report Date
    September 18, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 7922130 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 283 DAYS AFTER IMPLANTATION OF A 2.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE "MILDLY CALCIFIED" TARGET LESION WAS LOCATED IN THE "NON-TORTUOUS," MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION STENOSIS OF 80% WAS REPORTED. INITIAL ATTEMPTS TO CROSS THE LESION WITH A 2.0X20MM MAVERICK BALLOON AND A 2.5X16MM TAXUS STENT WERE UNSUCCESSFUL. A 2.75X20MM MAVERICK BALLOON WAS USED TO PERFORM ANGIOPLASTY. SUBSEQUENTLY, THE 2.5X16MM TAXUS STENT WAS DEPLOYED IN THE MID LAD IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PATIENT RECEIVED INTEGRILIN, NITROGLYCERIN, HEPARIN, AND INTRACORONARY VERAPAMIL DURING THE PROCEDURE. THE PROCEDURE WAS NOTED TO BE "SUCCESSFUL." THE PT REPORTEDLY "TOLERATED THE PROCEDURE WELL". THE PT PRESENTED 283 DAYS AFTER THE INITIAL PROCEDURE WITH A 60% IN-STENT RESTENOSIS IN THE MID LAD. ANGIOPLASTY WAS PERFORMED USING A 2.0X12MM MAVERICK BALLOON. A 2.5X18MM CYPHER STENT WAS DEPLOYED IN THE MID/DISTAL LAD IN THE REGION OF THE LESION. THE STENT WAS THEN POST-DILATED WITH A 2.75X12MM QUANTUM BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PT RECEIVED HEPARIN, INTEGRILIN, AND INTRACORONARY NITROGLYCERIN DURING; AND PLAVIX AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT "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 2.5X16MM 7922130

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R