BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 2990877 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01263
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN OMEGA STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO OTHER DEVICES. THERE WAS BLOOD AND CONTRAST IN THE GUIDE WIRE LUMEN. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WAS MULTIPLE STENT STRUT ROWS ON THE DISTAL END OF THE STENT WITH MULTIPLE STENT STRUTS STRETCHED AND BENT. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE CONFIRMED STENT 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. DURING INTRODUCTION, OUTSIDE THE PATIENT, THE 3.0 X 24 MM OMEGA MONORAIL STENT ROLLED UP AND COULD NOT BE USED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. DURING INTRODUCTION, OUTSIDE THE PATIENT, THE 3.0X24MM OMEGA MONORAIL STENT ROLLED UP AND COULD NOT BE USED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95032 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913824300 15691881

    Patients

    Seq Age Sex Outcome Treatment
    1