BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 2944130 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00572
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF AN OMEGA STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. THERE WERE MULTIPLE STENT STRUTS STRETCHED AND BENT IN THE DISTAL END OF THE STENT. THERE WERE STENT STRUT IMPRESSIONS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE; HOWEVER, THE DISTAL END OF THE STENT EXTENDED BEYOND THE DISTAL MARKERBAND. THE LOCATION OF THE STRUT IMPRESSIONS ON THE BALLOON INDICATES THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. MAGNIFIED INSPECTION PRESENTED NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DISTAL STENT DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS HANDLING DAMAGE AS EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 16 X 2.50MM OMEGA STENT WAS SELECTED FOR USE. NO ISSUES WERE NOTICED VISUALLY, BUT AFTER THE 'WRAPPER' WAS REMOVED FROM THE STENT AND THE 'PLASTIC COVER' OF THE TIP WAS REMOVED, STENT DAMAGE WAS NOTED. WHEN THE PHYSICIAN TOUCHED THE STENT, IT SEEMED THAT ONE OF THE STRUTS WAS UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 16 X 2.50MM OMEGA STENT WAS SELECTED FOR USE. NO ISSUES WERE NOTICED VISUALLY, BUT AFTER THE 'WRAPPER' WAS REMOVED FROM THE STENT AND THE 'PLASTIC COVER' OF THE TIP WAS REMOVED, STENT DAMAGE WAS NOTED. WHEN THE PHYSICIAN TOUCHED THE STENT, IT SEEMED THAT ONE OF THE STRUTS WAS UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49217 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913816250 15452170

    Patients

    Seq Age Sex Outcome Treatment
    1