BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 624958 · Received August 5, 2005

    Report

    Report Number
    6000093-2005-00877
    Event Type
    Injury
    Date Received
    August 5, 2005
    Date of Event
    February 16, 2005
    Report Date
    July 6, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AFTER INDEX IMPLANTATION THE TARGET LESION HAD 0% RESIDUAL STENOSIS. THE PATIENT PRESENTED 54 DAYS POST ARRIVE 2 ENROLLMENT WITH RECURRENT ANGINA. CARDIAC CATHETERIZATION REVEALED THAT THE LMCA WAS NORMAL. THE LAD HAD 70% NARROWING JUST PROXIMAL TO THE PREVIOUSLY PLACED STENT (WHICH APPEARS OVERSIZED, PER CATH REPORT), THE LCX WAS NORMAL, THE RCA HAD 50% AND 70% TANDEM MID STENOSIS, AND THE LVEF WAS 35%. A 3.0 X 8MM TAXUS STENT WAS THEN DEPLOYED IN THE MID LAD WITH 0% RESIDUAL STENOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 54 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT A TARGET VESSEL REINTERVENTION (TVR) OF THE MID LEFT ANTTERIOR DESCENDING ARTERY (LAD). TEH INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 2.75 MM VESSEL DIAMETER, 80% STENOSED REGION OF THE MID LAD. THE LESION WAS 10 MM IN LENGTH AND WAS BEING TREATED BECAUSE THE PATIENT WAS EXPERIENCING A MYOCARDIAL INFARCTION (MI). THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 2.75X16MM (LOT 6981072) DRUG ELUTING STENT WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS POST INDEX PROCEDURE RECEIVING ASA AND PLAVIX. THE SITE REPORTED THAT THE PATIENT UNDERWENT A TVR OF THE MID LAD 54 DAYS POST INDEX PROCEDURE TO ALLEVIATE PROXIMAL EDGE RESTENOSIS. THE PHYSICIAN TREATED THE TARGET VESSEL BY PLACING AN UNKNOWN STENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST TVR. IN THE OPINION OF THE PHYSICIAN THERE IS A PROBABLE RELATIONSHIP BETWEEN THE EVENT AND THE TAXUS STENT.

    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% 2.75 X 16 MM 6981072

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R