BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3791829 · Received May 6, 2014

    Report

    Report Number
    2134265-2014-02391
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THE STENT WAS DAMAGED. THE STENT STRUTS AT THE PROXIMAL END OF THE STENT WERE BUNCHED AND DISTORTED. THE BALLOON CONE'S PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND A KINK ON THE SHAFT 25MM PROXIMAL FROM THE MID-SHAFT BOND. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 2.5 X 16 MM, ECCENTRIC DE NOVO 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND NON CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. DURING PREPARATION, A 16 X 2.50MM TAXUS LIBERTÉ WAS SELECTED TO TREAT THE LESION BUT THE PHYSICIAN NOTICED THE STENT BODY WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 2.5 X 16 MM, ECCENTRIC DE NOVO 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND NON CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. DURING PREPARATION, A 16 X 2.50MM TAXUS¿ LIBERTÉ¿ WAS SELECTED TO TREAT THE LESION BUT THE PHYSICIAN NOTICED THE STENT BODY WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272171 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894016250 15886575

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR