BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1823913 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-03838
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: TACTILE INSPECTION OF THE RETURNED DEVICE REVEALED A SHAFT KINK LOCATED 18CM FROM THE TIP. MAGNIFIED INSPECTION OF THE DISTAL COMPONENTS REVEALED THAT THE STENT HAD MOVED 3.5MM DISTALLY. THE STENT WAS ALSO DAMAGED AT THE DISTAL END. THE FIRST TWO ROWS ON THE DISTAL END OF THE STENT WERE BENT BACK DISTALLY. THE OUTER DIAMETER OF THE UNDAMAGED PORTION OF THE STENT WAS MEASURED AND MET SPECIFICATIONS. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED THE 3.0X20MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. UPON REMOVAL OF THE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED THE 3.0X20MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. UPON REMOVAL OF THE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT 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 - MAPLE GROVE H7493893620300 12906861

    Patients

    Seq Age Sex Outcome Treatment
    1