BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1032889 · Received April 23, 2008

    Report

    Report Number
    2134265-2008-01174
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION 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, STENT DAMAGE OCCURRED. THE 80% STENOSED, CALCIFIED TARGET LESION WAS IN THE TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNKNOWN TYPE BALLOON. A 3.5X32MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE OSTIUM OF THE RCA. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 3.5X16MM TAXUS EXPRESS2 DES DISTAL TO THE 3.5X32MM TAXUS EXPRESS2 DES, BUT THE DEVICE GOT "HUNG UP" ON THE 3.5X32MM TAXUS EXPRESS2 DES AND THE DISTAL PORTION OF THE 3.5X16MM TAXUS EXPRESS2 DES STENT "BECAME BENT". THE 3.5X16MM TAXUS EXPRESS2 DES WAS REMOVED WITHOUT DIFFICULTY. THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER 3.5X16MM TAXUS EXPRESS2 DES DISTALLY, BUT THE DEVICE WOULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY USING AN UNKNOWN TYPE BALLOON. THERE WAS NO DAMAGE TO THE 3.5X32MM TAXUS EXPRESS2 DES WITH THE DEVICE REMAINING IMPLANTED IN ITS INTENDED LOCATION, WELL POSITIONED AND WELL APPOSED. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "FINE".

    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 3.5X16MM 11336454

    Patients

    Seq Age Sex Outcome Treatment
    1