BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1041261 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01347
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS IT WAS NOTED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK THAT OCCURRED IN THE HYPO-TUBE. THE BREAK WAS MEASURED AT APPROX 18.2CM DISTAL FROM THE CATHETER STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. A REVIEW OF THE MFG DOCUMENTS FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF RELEASE TO DISTRIBUTION. TAKING INTO CONSIDERATION THE THOROUGH EVAL AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE BOSTON SCIENTIFIC CORP DESIGN AND MANUFACTURE SPEC BUT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS AND ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 4/17/08. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENT TO THE CALCIFIED, TORTUOUS LESION, VESSEL LOCATION UNK. THE CATHETER BROKE CLOSE TO THE HUB. THEY WERE ABLE TO REMOVE THE DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE PRODUCT ANALYSIS REVEALED THE BREAK WAS NOT AT THE HUB.

    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 3.0X16MM 11170947

    Patients

    Seq Age Sex Outcome Treatment
    1