BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2874092 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-08081
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PULLED DISTALLY ON THE BALLOON. AS A RESULT THE PROXIMAL EDGE OF THE STENT WAS POSITIONED AT 1CM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE STENT WAS BUNCHED IN ITS MID- SECTION. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. AS THE BALLOON PROTECTOR ON THE 35X32MM LIBERTE STENT WAS REMOVED SLIGHT RESISTANCE WAS NOTED, AND UPON REMOVAL IT WAS NOTED THAT THE MIDDLE OF THE STENT WAS BUNCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AS THERE WAS NO CONTACT WITH THE PATIENT, NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. AS THE BALLOON PROTECTOR ON THE 35X32MM LIBERTE STENT WAS REMOVED SLIGHT RESISTANCE WAS NOTED, AND UPON REMOVAL IT WAS NOTED THAT THE MIDDLE OF THE STENT WAS BUNCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AS THERE WAS NO CONTACT WITH THE PATIENT, NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893832350 0013290525

    Patients

    Seq Age Sex Outcome Treatment
    1