BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIQ STENT, CORONARY, DRUG-ELUTING

    MDR report key: 1423793 · Received April 3, 2009

    Report

    Report Number
    2134265-2009-01389
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Report Date
    March 4, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS A TAXUS STENT, BUT IT WAS NOT CONFIRMED IF THE DEVICE WAS A TAXUS LIBERTE OR TAXUS EXPRESS2. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG-ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE OCCURRED. AN UNSPECIFIED TAXUS STENT WAS IMPLANTED SUCCESSFULLY BUT UPON REMOVAL OF THE BALLOON FROM THE STENT, RESISTANCE WAS ENCOUNTERED. WITH SOME DIFFICULTY, THE PHYSICIAN WAS ABLE TO REMOVE THE STENT DELIVERY SYSTEM WITHOUT INJURY OR FURTHER ISSUES. THERE WERE NO PT COMPLICATIONS AND THE PT'S CURRENT CONDITION IS LISTED AS "FINE". ADDITIONAL INFO WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1