BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1834208 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04068
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERLY TORTUOUS DISTAL RIGHT CORONARY ARTERY.. THE PHYSICIAN PRE-DILATED THE LESION WITH A NON BSC BALLOON. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 3.50X12MM TAXUS LIBERTE STENT. THE DEVICE WAS ADVANCED AND IT DID NOT CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, A GUIDEWIRE WAS INSERTED FOR PARALLEL WIRE TECHNIQUE, DEVICE WAS ADVANCED AGAIN AND IT DID NOT CROSS THE LESION. WHEN IT WAS REMOVED, IT WAS NOTED THE STENT EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612350 12727331

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: GRANDSLAM| GUIDE WIRES: ASAHI INTACH| GUIDE CATHETER:LAUNCHER 6F, SAL1.5SH| GUIDEWIRE RUNTHROUGH EXTRA FLOPPY| BALLOON: TAZUNA| INFLATION DEVICE: EVEREST| STENT: ENDEAVOR SPRINT 3.5-12