BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1792094 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03538
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 16, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED IN-STENT RESTENOSED CONCENTRIC LESION MEASURING 4.0MM IN DIAMETER AND 20MM IN LENGTH WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT CONTAINED A BEND OF SEVENTY DEGREES. THE LESION WAS PREDILATED WITH BOTH A 2.5X15MM APEX BALLOON AND A 3.0X10MM CUTTING BALLOON. A 4.0X28MM TAXUS LIBERTE DRUG ELUTING STENT WAS ADVANCED TO THE LESION, BUT RESISTANCE WAS FELT AND THE PHYSICIAN COULD NOT CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK INTO THE GUIDE CATHETER; HOWEVER, THE STENT DISLODGED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED BY STENTING THE PROXIMAL LEFT CIRCUMFLEX WITH A 3.5X28MM NON BSC STENT AND POST-DILATING WITH A 4.0X20MM QUANTUM BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS 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 - GALWAY H7493893628400 12650961

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 0.014 STABILIZER PLUS GUIDE WIRE| 3.0X10MM CUTTING BALLOON| 6FR EBU 3.5 GUIDE CATHETER| 2.5X15MM APEX BALLOON