BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 843147 · Received February 27, 2007

    Report

    Report Number
    6000089-2007-00283
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    December 6, 2006
    Report Date
    February 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT FOUND THE PRESENCE OF DISTAL STENT STRUT DAMAGE, A NUMBER OF STENT STRUTS APPEARED BUNCHED. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO VISUAL DEFECTS WERE OBSERVED UNDER MAGNIFICATION. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A RECOMMENDED SIZE GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. THE DAMAGE PRESENT ON THE STENT IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DEVICE UPON MEETING SOME FORM OF RESTRICTION DURING DELIVERY. FURTHER INFORMATION REPORTED DETAILED THAT THE PHYSICIAN EXPERIENCED SIGNIFICANT RESISTANCE DURING INSERTION OF THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH # 7992133 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON 02/22/2007. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THERE WAS DIFFICULTY CROSSING THE LESION. A 2.75X12MM TAXUS EXPRESS2 WAS ADVANCED TO THE SEVERELY CALCIFIED, DISTAL LEFT ANTERIOR DESCENDING ARTERY; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS OR INJURIES REPORTED. THE PATIENT STATUS IS LISTED AS GOOD. DEVICE ANALYSIS INDICATES STENT DAMAGE.

    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 2.75X12MM 7992133

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR