BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3111797 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03078
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 16, 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

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. MAGNIFIED AND VISUAL INSPECTION CONFIRMED THERE WAS NO DAMAGE TO THE STENT. THERE WAS A WHITE/CLEAR PIECE OF UNKNOWN FOREIGN MATERIAL STUCK IN THE PORT OF THE HUB. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED ARTERY. AFTER PREDILATION, A 3.0X20MM OMEGA STENT FAILED TO CROSS THE LESION. AFTER ITS REMOVAL, STENT DEFORMATION WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE WITHOUT DIFFICULTIES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED ARTERY. AFTER PREDILATION, A 3.0X20MM OMEGA STENT FAILED TO CROSS THE LESION. AFTER ITS REMOVAL, STENT DEFORMATION WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE WITHOUT DIFFICULTIES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212361 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820300 15671737

    Patients

    Seq Age Sex Outcome Treatment
    1