BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 824274 · Received March 5, 2007

    Report

    Report Number
    6000089-2007-00316
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    November 16, 2006
    Report Date
    February 7, 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
    FL, 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 6983603 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR #6000093-2007-00448. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO BIFURCATION LESION IN THE PROX LEFT ANTERIOR DESCENDING ARTERY (LAD) / 1ST DIAGONAL. THE LESION WAS 2.5 MM WIDE, 34 MM LONG AND 95% STENOSED. THERE WAS MILD CALCIFICATION AND MILD TORTUOUSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH OVERLAPPING TAXUS EXPRESS2 STENTS; A 2.5 X 24 MM AND A 2.5 X 16 MM. RESIDUAL STENOSIS WAS 0%. THE 1ST DIAGONAL WAS 99% STENOSED AND DILATED TO 50%. ANOTHER MANUFACTURER'S STENT WAS ALSO PLACED IN THE DISTAL LAD. THE PT REC'D GPIIB/IIIA INHIBITORS, ASPIRIN, AND PLAVIX DURING THE PROCEDURE. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. THE PT HAD A CARDIAC CATHETERIZATION ON DAY 698. THE PT WAS ADMITTED 5 DAYS LATER AND CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED THE NEXT DAY (DAY 704) DUE TO IN-STENT RESTENOSIS. VESSELS BYPASSED INCLUDED SVG TO MID OM, SVG TO R-PDA AND SVG TO LAD. PHYSICIAN NOTED THAT THE RELATIONSHIP TO TAXUS STENT WAS PROBABLE. THE PT WAS DISCHARGED FIVE DAYS LATER.

    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 16 MM 6962550

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R