BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1894364 · Received November 9, 2010

    Report

    Report Number
    2134265-2010-04996
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 DURING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 95% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.25X20MM PROMUS ELEMENT STENT WAS ADVANCED TO THE RCA BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND A PREDILATION BALLOON WAS ADVANCED TO THE LESION. AFTER SUCCESSFUL PREDILATION THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE PROMUS ELEMENT STENT; HOWEVER, AS THE DEVICE WAS BEING ADVANCED OVER THE GUIDEWIRE IT WAS NOTED THAT THE STENT STRUTS WERE DAMAGED. THE DEVICE WAS EXCHANGED FOR ANOTHER OF THE SAME STENT DELIVERY SYSTEM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. THIS PRODUCT IS ONLY (B)(4) APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320220 0013232672

    Patients

    Seq Age Sex Outcome Treatment
    1