BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA¿

    MDR report key: 2873079 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07829
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 21, 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

    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 APPROXIMATELY THREE MONTHS POST CORONARY STENTING INTERVENTION THE STENT WAS NOT WELL APPOSED. (B)(6) 2012, THE TARGET LESION WAS LOCATED IN A SVG GRAFT FROM THE SEVERELY CALCIFIED AORTA TO THE DISTAL RIGHT POSTERIOR DESCENDING ARTERY. THE PHYSICIAN IMPLANTED A 24X3.50 OMEGA STENT IN THE LESION WITH THE MID POINT OF THE STENT ON A HINGE POINT WITHIN THE SVG. IMPLANTATION REQUIRED AN UNSPECIFIED NON-COMPLIANT BALLOON AT A HIGH PRESSURE INFLATION TO APPOSE THE STENT WELL. THE STENT WAS NOT FULLY EXPANDED BUT APPEARED WELL APPOSED TO THE VESSEL WALL. STENT WAS NOT IVUSED. (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR UNSTABLE ANGINA AND KNOWN CORONARY ARTERY DISEASE. AN ANGIOGRAM WAS PERFORMED BY ANOTHER PHYSICIAN WHO NOTED THAT THE STENT WAS NOT WELL EXPANDED/APPOSED. THE DOCTOR IS QUESTIONING WHETHER THE STENT HAS FRACTURED DUE TO THE EXCESSIVE BENDING WITHIN THE SVG, HOWEVER THE STENT WAS NOT IVUSED AND A FRACTURE WAS NOT CONFIRMED. NO INTERVENTION WAS PERFORMED TO ADDRESS THE IMPLANTED STENT AS THE SVG WAS OCCLUDED PATIENT IS GOING TO BE TREATED MEDICALLY DUE TO LIFESTYLE RISK FACTORS. 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 H7493913824350 15253162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other