BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3883807 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03412
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 STENT DAMAGE OCCURRED. THE 99.5% STENOSED 34X27MM, ECCENTRIC, DE NOVO, TARGET LESION CONTAINED A >45 AND <90 DEGREE BEND AND WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING THE INSERTION OF A 6FR/35 NON-BSC GUIDE CATHETER AND A 185 PT2 GUIDE WIRE, PREDILATION WAS DONE WITH A 1.5X20MM NON-BSC BALLOON CATHETER, WHICH REDUCED THE STENOSIS TO 43%. A 20X2.50 MM OMEGA¿ BARE METAL STENT WAS SELECTED FOR USE TO TREAT THE TARGET LESION. DURING THE PROCEDURE, SIGNIFICANT RESISTANCE WAS MET WHILE TRYING TO ADVANCING THE CATHETER. THE PHYSICIAN THEN REMOVED THE STENT AND FOUND OUT THAT THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF A 2.5X18 STENT AND A 2.75X18 STENT FOLLOWED BY POSTDILATION WITH A 3.0X15 BALLOON CATHETER . NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361651 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820250 16567368

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR PT2 185| 6FR/35