BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1813260 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03679
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED KINKS IN THE HYPOTUBE. THERE WAS A KINK 2.4CM AND 21.2CM DISTAL TO THE STRAIN RELIEF. AN EXAMINATION OF THE BALLOON FOUND THAT THE BALLOON HAD BEEN INFLATED AND WAS NOT REFOLDED. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED AND DEFLATED WITH NO RESTRICTIONS NOTED. A 0.015 INCH SIZE MANDREL WAS INSERTED THROUGH THE WIRE LUMEN WITH NO RESTRICTIONS NOTED. 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 INITIALLY REPORTED THAT THE VESSEL WAS THEN PRE-DILATED WITH A MAVERICK 3.0X20MM BALLOON AT 48ATMS FOR 30SECONDS. THE CORRECT INFLATION TIME WAS 8 ATM FOR 30 SECONDS.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-03680 AND 2134265-2010-03682. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE FIRST TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-BSC JR4 GUIDE CATHETER AND NON-BSC GUIDE WIRE WERE ADVANCE TO THE LESION. THE VESSEL WAS THEN PRE-DILATED WITH A MAVERICK 3.0X20MM BALLOON AT 48ATMS FOR 30 SECONDS. A VERIFLEX 3.0X32MM BARE METAL STENT WAS ADVANCED AND INFLATED TO 10ATMS FOR 30 SECONDS AND 12 ATMS FOR 30 SECONDS. UPON ATTEMPTING TO WITHDRAW THE DELIVERY BALLOON IT WAS STUCK TO THE STENT. THE PHYSICIAN HAD TO PULL NEGATIVE A FEW TIMES IN ORDER TO REMOVE THE BALLOON. THIS OCCURRED TWO MORE TIMES WITH A VERIFLEX 4.0X16MM BARE METAL STENT AND A VERIFLEX 4.0X32MM BARE METAL STENT THAT WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PULLED NEGATIVE A FEW TIMES TO REMOVE THE BALLOON FROM THE STENTS. THE PROCEDURE WAS COMPLETED AND NOT PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432300 0013361233

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUNCHER JR4 GUIDE CATHETER| BMW GUIDE WIRE| MAVERICK 3.0X20MM BALLOON