BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1832845 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04032
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 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

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT A JAGGED TEAR EXISTED IN THE INNER AND OUTER SHAFT AT THE PORT SITE. THE TEAR STRETCHED FROM THE PORT TO APPROXIMATELY 2CM DISTAL FROM THE PORT. THIS TYPE OF TEAR IS CONSISTENT WITH THE GUIDEWIRE OR PRODUCT MANDREL BEING INCORRECTLY PULLED OUT THROUGH THE INNER AND OUTER SHAFTS AT THE PORT SITE. AN EXAMINATION OF THE CRIMPED STENT FOUND THAT THE PROXIMAL EDGE OF THE STENT WAS LIFTED. NO OTHER DAMAGE WAS NOTED. AS A RESULT OF THE TEAR IN THE INNER/OUTER SHAFT, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON IN ORDER TO DEPLOY THE STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED AS THE DEVICE IS INDICATED FOR STENOTIC LESIONS IN NATIVE CORONARY ARTERIES AND SAPHENOUS VEIN GRAFTS AND THE COMPLAINT REPORTS THE DEVICE WAS BEING USED TO TREAT THE BASILAR ARTERY. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO EXPAND. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED BASILAR ARTERY. A 3.5X16MM LIBERTE BARE STENT WAS ADVANCED TO THE LESION; HOWEVER, THE STENT WAS UNABLE TO EXPAND. THE PHYSICIAN CHANGED THE INFLATION DEVICE AND ATTEMPTED TO DEPLOY THE STENT AGAIN; HOWEVER, THE STENT WAS STILL UNABLE TO EXPAND. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893816350 0013463453

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR EMBOY 6FR GUIDE CATHETER| TRANSEND PLATINUM GUIDEWIRE