BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3180386 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04472
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE LIBERTÉ/VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS RECEIVED WITH THE STENT AND LIBERTÉ/VERIFLEX SHELF BOX. THE BATCH ON THE RETURNED PACKAGING AND THE HUB MATCHED THE REPORTED BATCH NUMBER. THERE WAS BLOOD IN THE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE STENT WAS SECURE ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WERE SEVERAL BENT AND FLARED STENT STRUTS ON THE PROXIMAL END OF THE STENT. THERE WAS NO DAMAGE TO THE SDS. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 MM X 12 MM LIBERTÉ STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS DUE TO THE STENT BEING "MISSHAPED DURING THE PROCEDURE". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 MM X 12 MM LIBERTÉ STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS DUE TO THE STENT BEING "MISSHAPED DURING THE PROCEDURE". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281596 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812250 15078506

    Patients

    Seq Age Sex Outcome Treatment
    1