BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3972607 · Received August 1, 2014

    Report

    Report Number
    2134265-2014-04527
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 A STENT DAMAGE OCCURRED. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF AN UNKNOWN STENT IMPLANTED IN 2007 AT THE TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY. THE 2.75MM X 16MM PROMUS PREMIER¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. AS THE DEVICE WAS PULLED BACK, MODERATE RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE PROXIMAL END OF THE STENT WAS FLARED. ANOTHER NON BSC STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE LESION. BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS DOING GREAT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450268 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952816270 16726129

    Patients

    Seq Age Sex Outcome Treatment
    1