BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA¿

    MDR report key: 2831591 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06881
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE AND THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS WIRED WITH A NON-BSC GUIDE WIRE THROUGH A 1.5MM OTW BALLOON. PROXIMAL TO THE LESION, THERE WAS A HUGE AMOUNT OF THROMBUS WITHIN THE ARTERY THAT THE PHYSICIAN SUGGESTED "APPEARS FRESH", THOUGH THERE WERE COLLATERALS FROM THE LEFT CIRCUMFLEX ARTERY. THE THROMBUS WAS TREATED WITH MULTIPLE RUNS OF THROMBECTOMY UNTIL THROMBUS WAS ASPIRATED AND FLOW WAS RESTORED TO WHAT WAS A HUGE VESSEL. THE TARGET LESION WAS PREDILATED WITH A 1.5MM AND 2.5MM NON BSC BALLOON. EXTENSIVE THROMBUS WAS STILL PRESENT AFTER PRE-DILATATION SO FURTHER ASPIRATION WAS PERFORMED INCLUDING VIA THE GUIDE CATHETER. EVENTUALLY THE THROMBUS WAS CLEARED AND THE PHYSICIAN DEPLOYED A 4.5X20MM OMEGA STENT AT 18ATMS. DURING IMAGING A SMALL FILLING DEFECT WAS OBSERVED IN THE STENT AND TISSUE HAD PROLAPSED THROUGH THE STENT SEGMENTS. THE STENT STRUTS WERE WELL OPPOSED BUT THERE WAS SOME SORT OF THROMBUS / PLAQUE PROLAPSE INTO THE UNTREATED PORTION OF THE VESSEL AND TWO SMALL VESSELS WERE OCCLUDED DURING THE PLACEMENT OF THE STENT. NO FURTHER ACTION WAS TAKEN DURING THE PROCEDURE; HOWEVER, THE PATIENT WAS SCHEDULED FOR ANOTHER PROCEDURE TWO WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493913820450 15235864

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other 2.5MM TREK BALLOON CATHETER| 1.5MM OTW BALLOON CATHETER| BALANCE GUIDE WIRE| 1.5MM TREK BALLOON CATHETER| EXPORT THROMBECTOMY ASPIRATOR