BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 694769 · Received March 29, 2006

    Report

    Report Number
    6000089-2006-00520
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    March 2, 2006
    Report Date
    March 3, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE COMPLAINT INCIDENT IS UNK. DEVICE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. FROM THE CONDITION OF THE RETURNED DEVICE, IT IS EVIDENT THAT THE PHYSICIAN EXPERIENCED SOME DIFFICULTIES DURING THE PROCEDURE. THE DAMAGE PRESENT IS CONSISTENT DURING THE PROCEDURE. THE DAMAGE PRESENT IS CONSISTENT WITH THE REPORTED COMPLAINT. THE DEVICE WAS RETURNED TOGETHER WITH THE CRIMPED STENT. VISUAL EXAMINATIN OF THE RETURNED UNIT FOUND THAT SOME OF THE DISTAL STENT STRUTS WERE SLIGHTLY DAMAGED, THEY APPEARED TO HAVE BEEN BENT BACK PROXIMALLY. NO FURTEHR DAMAGE WAS NOTED WITH THE RETURNED COMPLAINT. THIS BATCH HAS NO OTHER ASSOCIATED COMPLAINTS TO DATE. THE SHOP FLOOR PAPERWORK (SFP) AHS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SFP REVIEW CONFIRMED THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A CORONARY STENTING DRUG ELUTING TREATMENT PROCEDURE, STENT DAMAGE OCCURED. THE LESION BEING TREATED WAS LOCATED IN THE DIAGONAL (DX) ARTERY. THE PHYSICIAN PREDILATED WITH AN 2.5 MM MAVERICK BALLOON. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE TAXUS EXPRESS2 3.00 X 8 MM DRUG ELUTING STENT IT WOULD NOT CROSS THE LESION. WHEN THE DEVICE WAS PULLED BACK, TO ADVANCE AGAIN, IT WAS NOTICED THAT A FEW OF THE STENT STRUTS HAD COME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PT COMPLICATIONS WERE REPORTED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.00 X 8MM 8127346

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR