BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2093758 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01757
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE LIBERTE/VERIFLEX DEVICE WAS RECEIVED IN A LIBERTE/VERIFLEX INNER PACKAGING POUCH AND SHELF BOX. THE STENT WAS NOT PRESENT ON THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS). THERE WAS NO DAMAGE TO THE SDS AND NO EVIDENCE THAT THE DEVICE WAS PREPPED FOR CLINICAL USE. THE BALLOON WAS TIGHTLY FOLDED AND THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE STENT WAS INSIDE THE PROTECTIVE STENT TUBING (STENT PROTECTOR) WITH 2 MM OF THE STENT PROTRUDING OUT ONE END OF THE STENT PROTECTOR. THE STYLET END OF THE PRODUCT MANDREL WAS PROTRUDING FROM THE OTHER END OF THE STENT PROTECTOR. THE STENT APPEARED TO BE LARGER IN DIAMETER AT THE END THAT WAS PROTRUDING FROM THE STENT PROTECTOR; THE STRUTS IN SEVERAL ROWS WERE SLIGHTLY EXPANDED. THE STENT WAS REMOVED FROM THE STENT PROTECTOR WITH A TWEEZERS WITH MINIMAL FORCE. THE MAXIMUM STENT OUTSIDE DIAMETER (OD) AT THE END THAT PROTRUDED FROM THE STENT PROTECTOR WAS .04580". THE MAXIMUM OD OF THE REST OF THE STENT WAS .04249". THE MAXIMUM BALLOON CONE OD WAS .04228" (PROXIMAL) AND .04391" (DISTAL). THE INNER DIAMETER OF THE STENT PROTECTOR WAS MEASURED AT .041". ALL MEASURED DIMENSIONS OF THE STENT AND SDS MET THE RESPECTIVE SPECIFICATIONS. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED; HOWEVER, THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DISLODGMENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 2.75X16MM VERIFLEX STENT CAME OFF THE STENT DELIVERY BALLOON DURING THE REMOVAL OF THE STYLET. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893516270 13614587

    Patients

    Seq Age Sex Outcome Treatment
    1