BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2150393 · Received July 6, 2011

    Report

    Report Number
    2134265-2011-02792
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF AN OMEGA STENT DELIVERY SYSTEM (SDS) WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS NOT ANY BLOOD OR CONTRAST VISIBLE. STENT STRUTS WERE STRETCHED STARTING AT THE NINTH PROXIMAL ROW EXTENDING 1 CM PAST THE DISTAL MARKERBAND. THERE WAS NO OTHER DAMAGE TO THE STENT. THERE WAS NO DAMAGE TO THE SDS. THE REPORTED STENT DISLODGEMENT WAS IDENTIFIED AS THE STRETCHED STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OUTSIDE OF THE PATIENT OCCURRED. WHEN THE PHYSICIAN TOOK THE 2.25X20MM OMEGA STENT FROM THE PACKAGE, HE FOUND THE STENT HAD COME OFF FROM THE STENT DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY. 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 A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OUTSIDE OF THE PATIENT OCCURRED. WHEN THE PHYSICIAN TOOK THE 2.25X20MM OMEGA STENT FROM THE PACKAGE, HE FOUND THE STENT HAD COME OFF FROM THE STENT DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY. 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
    1 OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820220 14090488

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR