BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2213075 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03393
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFG: RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX MONORAIL STENT DELIVERY SYSTEM (SDS) WITH THE STENT DETACHED/SEPARATED. THERE WAS DRIED CONTRAST IN THE INFLATION LUMEN. THERE WAS STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. AS-RECEIVED, THE BALLOON WAS IN A LOOSELY FOLDED CONDITION WITH SOME POSITIVE PRESSURE APPLIED. THE STENT WAS PARTIALLY DEPLOYED WITH SOME POSITIVE PRESSURE APPLIED. MAGNIFIED INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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

    REPORTABLE BASED ON THE ANALYSIS COMPLETED (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, THE 2.50X12MM LIBERTE BARE MR STENT WOULD NOT CROSS THE LESION. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THERE WERE TWO LESIONS IN THE RIGHT CORONARY ARTERY(RCA). RCA SEGMENT TWO WAS DILATED WITH A 2.0X12MM MAVERICK WITH GOOD RESULTS. SEGMENT ONE WAS A 3.5X12MM LESION WAS LOCATED IN THE 50% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). LESION WAS ECCENTRIC IN SHAPE, PROGRESSIVE AND INVOLVED A SIGNIFICANT BEND LESS THAN 45 DEGREES. THE PHYSICIAN ADVANCED THE 2.50X12MM LIBERTE STENT SYSTEM BUT WAS NOT ABLE TO CROSS THE LESION. THE LESION WAS THEN DILATED WITH A 2.0X12MM MAVERICK BALLOON AND PHYSICIAN ATTEMPTED TO DELIVER THE SAME 2.50X12MM LIBERTE STENT BUT AGAIN WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH 2.5X16MM LIBERTE SENT WITH GOOD RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812250 13350206

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GUIDE CATHETER: RUNWAY FR4| GUIDE WIRE: BMW .014