BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1727191 · Received June 17, 2010

    Report

    Report Number
    2134265-2010-02626
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(6). DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION AND CORRECTION OF DEVICE FROM 3.0X32MM TAXUS LIBERTE' DRUG ELUTING STENT TO A 3.0X32MM VERIFLEX BARE METAL STENT. BRAND NAME - CORRECTED FROM "TAXUS LIBERTE' PAXLITAXEL-ELUTING CORONARY STENT SYSTEM" TO "VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM". COMMON DEVICE NAME - CORRECTED FROM "CORONARY DRUG-ELUTING STENT" TO "STENT, CORONARY". (B)(4). (B)(4). CATALOG/MODEL# - CORRECTED FROM 38936-3230 TO 38934-3230. DEVICE LOT NUMBER - CORRECTED FROM 12883849 TO UNKNOWN. ADDITIONAL INFORMATION: (B)(6) 2010 2.5X15MM TAZUNA BALLOON, HEARTRAIL GUIDE CATHETER, 0.014 INCH RUNTHROUGH GUIDEWIRE. PMA# OR 510K# - CORRECTED FROM P060008 TO P040016. DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL INFORMATION: AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS A 3.0X32MM VERIFLEX BARE METAL STENT, NOT A 3.0X32MM TAXUS LIBERTE' DRUG ELUTING STENT AS PREVIOUSLY REPORTED. THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER VERIFLEX BARE METAL STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. A 3.0X32MM TAXUS LIBERTE' DRUG ELUTING STENT WAS ADVANCED THROUGH THE GUIDE CATHETER, BUT RESISTANCE WAS FELT. THE DEVICE WAS REMOVED FROM THE PATIENT AND DISTAL STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. NO PATIENT INJURIES OR COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS "GOOD."

    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 12883849

    Patients

    Seq Age Sex Outcome Treatment
    1