BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3111474 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03042
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD ON THE BALLOON. THE BALLOON WAS TIGHTLY FOLDED. THE STENT WAS SECURE ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WERE MULTIPLE STRUTS LIFTED AND FLARED IN THE FIRST TWO DISTAL ROWS OF STENT STRUTS. THERE WERE MULTIPLE KINKS THROUGHOUT THE HYPOTUBE. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 97% STENOTIC, 25MM LONG LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY WHICH HAD A GREATER THAN 90 DEGREE BEND. THE PHYSICIAN ADVANCED A 2.5X20MM LIBERTE STENT TO THE LESION BUT WAS UNABLE TO CROSS "WITH THIS DEVICE BECAUSE OF THE STRUT DAMAGE". THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X20MM LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 97% STENOTIC, 25MM LONG LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY WHICH HAD A GREATER THAN 90 DEGREE BEND. THE PHYSICIAN ADVANCED A 2.5X20MM LIBERTE STENT TO THE LESION BUT WAS UNABLE TO CROSS "WITH THIS DEVICE BECAUSE OF THE STRUT DAMAGE". THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5X20MM LIBERTE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212707 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893820250 14843796

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0.14 EXTRA SUPPORT GUIDEWIRE