BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1053522 · Received May 27, 2008

    Report

    Report Number
    2134265-2008-01516
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-01515. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT MIGRATION AND EXPLANT OCCURRED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS NOT PREDILATED. THE PHYSICIAN DEPLOYED TWO 2.50X8MM TAXUS EXPRESS2 DRUG ELUTING STENTS OVERLAPPING IN THE PROXIMAL CX, INFLATED TO 12 ATMS FOR 20 SECONDS. STENOSIS WAS REDUCED TO 0%. VERAPAMIL WAS GIVEN FOR SEVERE CORONARY ARTERY SPASM AND THE VESSELS DOUBLED IN SIZE. THE STENTS MIGRATED TO THE LEFT MAIN (LM) AND THEN TO THE LEFT ANTERIOR DESCENDING (LAD). THE PHYSICIAN USED A 2.75X12MM MAVERICK BALLOON TO RETRIEVE THE STENTS FROM THE LAD, INFLATED TO 10ATMS. THE SDS AND STENTS WERE REMOVED AS A WHOLE. THE STENTS ARE BELIEVED TO BE ONE INSIDE THE OTHER. MEDICATIONS GIVEN: HEPARIN, INTEGRILIN, VERSED, VERAPAMIL, PLAVIX, PROTAMINE, FENTANYL, NTG. ANOTHER PHYSICIAN ATTEMPTED TO PULL THE STENTS APART AFTER THE STENTS WERE REMOVED FROM THE PATIENT, IN ORDER TO CONFIRM 2 STENTS WERE RETRIEVED. IN DOING SO, THE STENTS BECAME DISTORTED.

    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 2.50X8 MM 11468818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention