BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 703353 · Received April 20, 2006

    Report

    Report Number
    6000089-2006-00649
    Event Type
    Injury
    Date Received
    April 20, 2006
    Date of Event
    July 20, 2005
    Report Date
    March 22, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 6000089-2006-00650. 16 MONTHS AFTER IMPLANTATION OF TAXUS EXPRESS2 DRUG ELUTING STENTS, THE PT REQUIRED A TARGET VESSEL REINTERVENTION (TVR) CONSISTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. DURING THE INITIAL PROCEDURE, TARGET LESIONS WERE LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND THE RIGHT ATRIOVENTRICULAR BRANCH (R-PAV). THE LESION IN THE R-PDA WAS AN OSTIAL LESION WITH 90% OCCLUSION, MILD CALCIFICATION AND MILD TORTUOSITY. IT WAS TREATED WITHOUT PRE-DIALATION WITH A 3X8 MM TAXUS EXPRESS2 DRUG ELUTING STENT. IT WAS THEN POST-DIALATED. THE LESION IN THE R-PAV WAS 90% OCCLUDED WITH MILD CALCIFICATION AND MILD TORTUOSITY. IT WAS TREATED WITHOUT PREDIALATION WITH A 2.75 X 8MM TAXUS EXPRESS2 STENT. IT WAS NOT POST-DIALATED. APPROX 16 MONTHS LATER, THE PT REQUIRED CABG SURGERY IN THE RIGHT CORONARY ARTERY AND THE R-PDA. THE RELATIONSHIP TO THE TAXUS STENT WAS REPORTED AS UNK AND THERE WAS NO RESTENOSIS IN THE R-PDA STENT. THE PT WAS DISCHARGED 11 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75 X 8.0 MM 6091401

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R