BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001144 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00339
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 23, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER -THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, CONCENTRIC, ANASTOMOTIC LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS, NON-CALCIFIED LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS PREDILATED WITH A 2.0X15MM APEX BALLOON, INFLATED TWICE TO 13ATMS FOR 30 SECONDS. THE PHYSICIAN IMPLANTED A 2.25X20 TAXIS LIBERTE ATOM STENT, INFLATED TO 11ATMS FOR 15 SECONDS. POST DILATATION WAS PERFORMED WITH A 2.5X8MM QUANTUM MAVERICK BALLOON, INFLATED TO 7ATMS FOR 15 SECONDS. MEDICATIONS GIVEN INCLUDED: INTEGRILIN AND LOVENOX. PLAVIX WAS PRESCRIBED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. TWO DAYS POST THE INITIAL STENTING PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THROMBOSIS WAS DIAGNOSED AND UNSPECIFIED TREATMENT WAS PERFORMED. THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620220 13397754

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention