BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1001742 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00478
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE 95% STENOSED, CALCIFIED, TARGET LESION WAS IN THE EXTREMELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AN UNK TYPE BALLOON CATHETER. THE PHYSICIAN HAD SELECTED AND ATTEMPTED TO ADVANCE A 2.5X12MM TAXUS EXPRESS2 DRUG ELUTING STENT BUT "IT WAS DIFFICULT". THE PHYSICIAN "PUSHED" AND THE HYPOTUBE KINKED. DURING WITHDRAWAL, THE DEVICE FRACTURED AT KINK AT THE DISTAL SIDE OF THE HUB. THE DEVICE WAS OUTSIDE THE PT'S BODY WHEN THE FRACTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 2.5X16MM TAXUS EXPRESS2 DES. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    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 2.5X12MM 9690557

    Patients

    Seq Age Sex Outcome Treatment
    1