BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 828588 · Received March 12, 2007

    Report

    Report Number
    6000093-2007-00499
    Event Type
    Injury
    Date Received
    March 12, 2007
    Date of Event
    January 12, 2006
    Report Date
    February 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    K030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7001373 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. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 3 MM WIDE, 113 MM LONG, AND 85% STENOSED. THE LESION HAD MODERATE CALCIFICATION. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 3.0 X 16 MM TAXUS EXPRESS2 STENT. POSTDILATATION STENOSIS WAS 0%. THE PT REC'D ASPIRIN, PLAVIX, AND ANGIOMAX DURING THE PROCEDURE. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 646, THE PT HAD A TVR TO THE PROX CX AT A NON ENROLLING HOSPITAL. POBA WAS PERFORMED FOR IN-STENT RESTENOSIS. THE PT WAS DISCHARGED ONE DAY LATER. IN THE OPINION OF THE PHYSICIAN, THERE WAS AN UNKNOWN RELATIONSHIP BETWEEN THE TVR AND THE TAXUS STENT.

    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. 3.0 X 16 MM 7001373

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R