BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 845840 · Received May 3, 2007

    Report

    Report Number
    6000093-2007-00892
    Event Type
    Injury
    Date Received
    May 3, 2007
    Date of Event
    June 2, 2006
    Report Date
    April 5, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 6992040 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MFR #6000093-2007-00891. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD 2 TARGET VESSEL REVASCULARIZATIONS. THE INDEX PROCEDURE TREATED 2 LESIONS. TARGET LESION 1 WAS A DE NOVO LESION IN THE 3RD DIAGONAL. THE LESION WAS 3.5 MM WIDE, 20 MM LONG, AND 70% STENOSED. THERE WAS MODERATE CALCIFICATION AND MILD TORTUOSITY. THE PHYSICIAN PRE DILATED THE LESION PRIOR TO PLACING A 3.0 X 20 MM TAXUS EXPRESS2 STENT. TARGET LESION 2 WAS A DE NOVO LESION IN THE RAMUS. THE LESION WAS 2.75 MM WIDE, 10 MM LONG, AND 70% STENOSED. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 2.5 X 12 MM TAXUS EXPRESS2 STENT. POST DILATATION STENOSIS WAS 0% FOR BOTH LESIONS. THE PHYSICIAN USED IVUS DURING THE PROCEDURE. THE PT RECEIVED PLAVIX AND A GPIIB/IIIA INHIBITOR DURING THE PROCEDURE. THE PT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PLAVIX. ON DAY 564, THE PT HAD A TVR IN THE 3RD DIAGONAL DUE TO FOCAL IN STENT RESTENOSIS. THE TVR CONSISTED OF A CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF ANOTHER MANUFACTURERS STENT. THE PT ALSO HAD A TVR IN THE RAMUS DUE TO DIFFUSE IN STENT RESTENOSIS. THE TVR CONSISTED OF A CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF A TAXUS EXPRESS2 STENT. THE PT WAS DISCHARGED 4 DAYS LATER. THE SITE WAS UNAWARE OF THE EVENT UNTIL A MANUAL REVIEW ON 4/4/07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORP. 2.5 X 12 MM 6992040

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R