BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1840189 · Received September 21, 2010

    Report

    Report Number
    2134265-2010-04284
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DELIVERY DEVICE WAS RECEIVED WITHOUT THE STENT. AN EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON HAD BEEN INFLATED. THERE WAS A BUILD UP OF SOLIDIFIED CONTRAST MEDIA PRESENT INSIDE THE BALLOON. A CLEAR IMPRESSION WAS VISIBLE ON THE BALLOON MATERIAL OF WHERE THE STENT HAD BEEN CRIMPED INITIALLY. IT IS CLEAR THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE (EVIDENT WITH THE CONTRAST MEDIA INSIDE THE BALLOON). 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 CORONARY ARTERY STENTING PROCEDURE, THE STENT WAS NOT ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S STENT WAS PLACED IN THE DISTAL RCA. THE VERIFLEX STENT WAS ADVANCED INTO POSITION IN THE RCA, BUT WAS UNABLE TO BE VISUALIZED ON FLUOROSCOPY. THE STENT DELIVERY SYSTEM WAS REMOVED AND THE BALLOON WAS INFLATED OUTSIDE THE PATIENT'S BODY; HOWEVER, NO STENT WAS PRESENT. THE STENT WAS UNABLE TO BE LOCATED WITHIN THE RCA, THE PACKAGING OR THE PROCEDURE ROOM. THE SITE THINKS THAT THERE WAS NO STENT ON THE CATHETER TO BEGIN WITH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AT THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893416450 0013552505

    Patients

    Seq Age Sex Outcome Treatment
    1