BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 600565 · Received May 6, 2005

    Report

    Report Number
    6000089-2005-00711
    Event Type
    Injury
    Date Received
    May 6, 2005
    Date of Event
    January 31, 2005
    Report Date
    April 15, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MDR 6000089-2005-00712. 329 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PT EXPERIENCED A STENT THROMBOSIS (ST) AND UNDERWENT A TARGET VESSEL REINTERVENTION (TVR) OF THE RAMUS ARTERY. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. TARGET LESION 1 WAS A 2.25 MM VESSEL DIAMETER, 80% STENOSED BIFURCATED REGION OF THE RAMUS ARTERY. TARGET LESION 2 WAS A 2.25 MM VESSEL DIAMETER, 95% STENOSED OSTIAL ANTERIOR SIDE BRANCH OF THE RAMUS ARTERY. THE PHYSICIAN PREDILATED BOTH TARGET LESIONS PRIOR TO PERFORMING THE BIFURCATED CRUSH TECHNIQUE. THE PHYSICIAN SUCCESSFULLY PLACED TWO TAXUS EXPRESS2 8.8% 2.5 X 12 MM (LOT 6080107) DRUG ELUTING STENTS INTO THE TARGET LESIONS. THE DRUG ELUTING STENT PLACED IN TARGET LESION 2 WAS POST DILATED AFTER DEPLOYMENT. BOTH DRUG ELUTING STENTS OVERLAP BY 6.0 MM. THE PT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS POST INDEX PROCEDURE RECEIVING PLAVIX, AND ASA. THE SITE REPORTED THAT THE PT EXPERIENCED AN ST AND UNDERWENT A TVR TO ALLEVIATE PROXIMAL EDGE RESTENOSIS OF THE RAMUS ARTERY 329 DAYS POST INDEX PROCEDURE. IT WAS REPORTED THAT THE TVR WAS ABORTED AFTER THE ANGIOPLASTY BALLOON WOULD NOT CROSS THE TARGET LESION. THE ST WAS RESOLVED BEFORE THE PT WAS DISCHARGED FROM THE HOSPITAL. THE ACTIONS LISTED TO RESOLVE THE ST INCLUDED HOSPITALIZATION, TVR, AND CARDIAC MEDICATION CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.50 X 12 MM 6080107

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention