BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2990927 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01354
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH THE STENT PROTECTOR AND PRODUCT MANDREL PARTIALLY LOADED. THERE WAS BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN. THE PRESENCE OF BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN, AND THE POSITION OF THE STENT PROTECTOR AND PRODUCT MANDREL SUGGEST THE STENT PROTECTOR AND PRODUCT MANDREL WERE REPLACED AFTER THE REPORTED STENT DAMAGE WAS NOTICED. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THE FIRST PROXIMAL STENT STRUT ROW HAD TWO STENT STRUTS STRETCHED AND BENT. THE DISTAL TIP WAS DAMAGED. THE MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CONFIRMED STENT AND TIP DAMAGE. A THOROUGH ANALYSIS OF THE RETURNED DEVICE COULD CONFIRM THE REPORTED STENT DAMAGE. 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 AN ANGIOPLASTY TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION, THE PHYSICIAN IDENTIFIED THE STENT STRUTS OF A 2.75X16MM LIBERTE STENT WERE DAMAGED AND THE DEVICE COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95104 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816270 15118025

    Patients

    Seq Age Sex Outcome Treatment
    1