BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 753614 · Received August 18, 2006

    Report

    Report Number
    6000093-2006-01564
    Event Type
    Injury
    Date Received
    August 18, 2006
    Date of Event
    March 1, 2006
    Report Date
    July 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED AS OF THIS REPORT THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 320 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD A NON-Q WAVE MYOCARDIAL INFARCTION (MI). THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 16 ATMS. THE PHYSICIAN IMPLANTED A 3X24MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 16 ATMS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PLAVIX. THE PATIENT HAD A NON-Q WAVE MI 320 DAYS POST-INDEX PROCEDURE. NO CK-MB WERE DRAWN AT THE TIME OF THE MI. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X24MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening