BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 811678 · Received January 30, 2007

    Report

    Report Number
    6000093-2007-00197
    Event Type
    Injury
    Date Received
    January 30, 2007
    Date of Event
    July 11, 2006
    Report Date
    January 3, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 6963433 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 STUDY. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 3 MM WIDE, 30 MM LONG, AND 80% STENOSED. THERE WAS MILD TORTUOUSITY. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 3.0 X 32 MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT RECEIVED ANGIOMAX, ASPIRIN AND PALVIX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 600, THE PATIENT HAD A TVR IN THE PROXIMAL CX DUE TO FOCAL IN-STENT RESTENOSIS. ANOTHER MANUFACTURERS STENT WAS PLACED. OF NOTE, THE PATIENT WAS NOT TAKING PLAVIX AT THE TIME OF THE EVENT. THE PATIENT WAS DISCHARGED ONE DAY LATER. IN THE OPINION OF THE PHYSICIAN, THERE IS 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 32 MM 6963433

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R