BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 3083468 · Received April 29, 2013

    Report

    Report Number
    2134265-2013-02857
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE HAD BROKEN AND ONLY THE PROXIMAL SECTION, WHICH WAS 68.5CM IN LENGTH, OF THE DEVICE WAS RETURNED. THE DISTAL SECTION OF THE DEVICE INCLUDING THE TIP AND STENT WERE NOT RETURNED FOR ANALYSIS. KINKS WERE ALSO NOTED ALONG THE PART OF THE HYPOTUBE RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK AND STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA RIGHT RADIAL ARTERY. THE 60% STENOSED 3.0X20MM, DE NOVO AND CONCENTRIC TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ANTERIOR DESCENDING ARTERY. A 24 X 3.00MM TAXUS LIBERTÉ DRUG ELUTING STENT WAS ADVANCED OVER THE GUIDEWIRE. WHEN THE SHAFT REACHED THE TARGET LESION, FLUOROSCOPY WAS PERFORMED PRIOR TO DEPLOYING THE STENT BUT THE STENT WAS NOT SEEN DURING FLUOROSCOPY. SO THE STENT DELIVERY SYSTEM WAS REMOVED AND THEY NOTED THAT THE SHAFT WAS BROKEN AND THE STENT WAS NO LONGER ATTACHED TO THE DELIVERY BALLOON CATHETER. EMBOLIZATION WAS SUSPECTED SO THEY PERFORMED FLUOROSCOPY AND THEY FOUND OUT THAT THE STENT IN THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183818 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894024300 15256762

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other CHOICE INTERMEDIATE GUIDE WIRE| MACH1 FL 3.5 6FR