BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3855178 · Received June 9, 2014

    Report

    Report Number
    2134265-2014-03162
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 30MM X 2.75MM, 85% STENOSED, ECCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY WITH A SIGNIFICANT BEND OF >45 AND <90 DEGREES. AFTER ADVANCEMENT OF A NON BSC GUIDEWIRE, PREDILATION WAS PERFORMED WITH THE USE OF A NON BSC BALLOON CATHETER. A 32X2.75 OMEGA¿ STENT DELIVERY SYSTEM WAS SELECTED TO TREAT THE LESION. THE NURSE REMOVED THE STENT FROM THE SLEEVE AND PREPARED IT BEFORE PASSING OVER TO THE PHYSICIAN. AS THE PHYSICIAN BEGAN TO THREAD THE STENT OVER THE WIRE, HE FOUND THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335467 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913832270 15830944

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR