BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2802782 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06461
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: 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 A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 2.5 X 28 MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE STENT WAS "LIFTED". THE PROCEDURE WAS COMPLETED WITH A 2.5 X 30 MM NON BSC STENT BY A 2 WIRE TECHNIQUE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 15016839

    Patients

    Seq Age Sex Outcome Treatment
    1