BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1950156 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05788
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    SAME CASE AS MFR #: 2134265-2010-05737. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY SHORT, CALCIFIED AND ECCENTRIC LEFT MAIN (LM) ARTERY WHERE THERE WAS 50% STENOSIS IN THE OSTIAL. AN 8X4.0MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED AT 16ATMS WITH PART OF THE STENT PARTIALLY POSITIONED IN THE AORTA. IVUS WAS PERFORMED AND THE STENT WAS POST DILATED WITH A 4.5X8MM NC QUANTUM APEX INFLATED TO 16 ATMS. IVUS WAS PERFORMED AGAIN AFTER POST-DILATATION HOWEVER THEY COULD NOT LOCATE THE STENT. A NEW 8X4.0MM TAXUS LIBERTE SDS WAS ADVANCED TO THE SAME LESION AND THE STENT WAS DEPLOYED AT 16ATMS. IMMEDIATELY AFTER DEPLOYING THE STENT IT WAS POST DILATED WITH A 5.0X8MM NC QUANTUM APEX BALLOON TO 16ATMS. IVUS WAS PERFORMED BUT THE PHYSICIAN COULD NOT LOCATE THE STENT. THE FACILITY CHECKED THE GUIDE CATHETER AND WIRE BUT COULD NOT FIND THE STENTS. A SCAN OF THE HEART WAS ALSO COMPLETED BUT THEY WERE UNABLE TO LOCATE THE STENTS. THE END RESULT ANGIOGRAPHICALLY LOOKED GOOD UNDER IVUS, HOWEVER THE STENTS WERE NOT VISUALIZED IN THE LOCATION THAT THEY WERE DEPLOYED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 - MAPLE GROVE H749389368400 13092796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5.0X8 NC QUANTUM APEX BALLOON CATHETER| PT2 GUIDE WIRE| ICROSS CATHETER| 7F EB CORDIS GUIDE CATHETER