BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

    MDR report key: 769494 · Received August 7, 2006

    Report

    Report Number
    6000089-2006-01619
    Event Type
    Malfunction
    Date Received
    August 7, 2006
    Date of Event
    February 27, 2006
    Report Date
    February 27, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS BENT BACK DISTALLY. NO OTHER ISSUES WERE NOTED WITH THE REMAINDER OF THE STENT OR WITH THE ACTUAL DELIVERY DEVICE. THE RECOMMENDED SIZE GUIDEWIRE WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH (REFERENCE TOP ASSEMBLY BATCH 6993851 & MANIFOLD BATCH 6891150) SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE DAMAGE FOUND AT THE PROXIMAL EDGE OF THE STENT IS CONSISTENT WITH THE STENT GETTING CAUGHT ON A FOREGIN OBJECT DURING WITHDRAWAL. NO ISSUES WERE IDENTIFIED WITH THE PROFILE OF THIS DEVICE THAT COULD CONTRIBUTE TO THE DIFFICULTIES THAT WAS EXPERIENCED BY THE PHYSICIAN DURING HIS ATTEMPTS TO CROSS THE LESION.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANAYLSIS COMPLETED ON 07/31/2006. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS STENT DAMAGE. THE INDEX PROCEDURE IDENTIFIED A LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DE NOVO LESION WAS 80% STENOSED, AND MODERATELY CALCIFIED. THE VESSEL WAS 3.5MM IN DIAMETER AND SEVERELY TORTUOUS. THE PHYSICIAN PRE-DILATED THE LESION WITH A 3.0MM BALLOON. THE PHYSICIAN ADVANCED A TAXUS EXPRESS2 3.50X28MM STENT TO THE LESION. THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH THE STENT. THE DEVICE WAS REMOVED PRIOR TO DEPLOYMENT. EXAMINATION OF THE DEVICE DISCOVERED THERE WAS PROXIMAL DAMAGE TO THE STENT STRUTS. THE PROCEDURE WAS ENDED WITHOUT PLACEMENT OF ANOTHER STENT. THE PATIENT STATUS WAS LISTED AS "SATISFIED/GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.50X28MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR