BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3192299 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04333
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THE FOURTH (4), FIFTH (5), SIXTH (6) AND SEVENTH (7) ROWS OF STRUTS ON THE DISTAL END OF THE STENT WERE BENT, FLARED AND OVERLAPPING. MAGNIFIED INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE REPORTED DISLODGED STENT WAS NOT CONFIRMED. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT SECUREMENT ISSUE OCCURRED. AS THE 4.5X20MM OMEGA STENT WAS OPENED AND PREPPED FOR USE THE PHYSICIAN NOTED THAT THE STENT WAS VERY LOOSE ON THE BALLOON AND NOT CRIMPED ON VERY WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.5X20MM OMEGA STENT. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT SECUREMENT ISSUE OCCURRED. AS THE 4.5X20MM OMEGA STENT WAS OPENED AND PREPPED FOR USE THE PHYSICIAN NOTED THAT THE STENT WAS VERY LOOSE ON THE BALLOON AND NOT CRIMPED ON VERY WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.5X20MM OMEGA STENT. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294394 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820450 0015890956

    Patients

    Seq Age Sex Outcome Treatment
    1