BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ¿

    MDR report key: 2923216 · Received January 18, 2013

    Report

    Report Number
    2134265-2013-00004
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    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

    DEVICE AVAIL. FOR EVAL - UPDATED. RETURNED TO MFR ON - UPDATED. DEVICE RETURNED TO MFR - UPDATED. DEVICE EVALUATED BY MFR - UPDATED. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A LIBERTE-VERIFLEX STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT HAD MOVED ON THE BALLOON 9MM DISTALLY FROM THE PROXIMAL MARKERBAND AND THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS. THE TIGHTLY FOLDED BALLOON INDICATED THE DEVICE WAS SUBJECTED TO NO POSITIVE (INFLATION) PRESSURE. THE THIRD AND FOURTH PROXIMAL STENT STRUT ROWS HAD MULTIPLE STENT STRUTS STRETCHED AND BENT. THE MAGNIFIED INSPECTION PRESENTED NO 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. WHILE REMOVING THE COVER SHEATH FROM THE 4.00 MM X 16 MM LIBERTE STENT, STENT DAMAGE WAS NOTED. THIS OCCURRED DURING PREPARATION, OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. WHILE REMOVING THE COVER SHEATH FROM THE 4.00 MM X 16 MM LIBERTE STENT, STENT DAMAGE WAS NOTED. THIS OCCURRED DURING PREPARATION, OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27669 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816400 15359542

    Patients

    Seq Age Sex Outcome Treatment
    1