BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3925534 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-03925
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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 STENT DAMAGE OCCURRED. A 38 X 3.50 PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED AND ADVANCED TO TREAT THE UNSPECIFIED TARGET VESSEL BUT WAS UNABLE TO CROSS DESPITE SEVERAL ATTEMPTS. THE DEVICE WAS THEN REMOVED AND IT WAS FOUND OUT THAT THE MIDDLE PART OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403395 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925138350 16936756

    Patients

    Seq Age Sex Outcome Treatment
    1