BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3863924 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03149
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25MM X 32MM PROMUS PREMIER STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. UPON REMOVAL OF THE DEVICE, IT CAME IN CONTACT WITH AN UNSPECIFIED GUIDE CATHETER WHICH CAUSED THE PROXIMAL EDGE OF THE STENT TO FLARE. ONCE THE DEVICE WAS TAKEN OUT FROM THE PATIENT, IT WAS THEN NOTICED THAT THE STENT WAS DEFORMED. THE STENT WAS NEVER IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341414 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952832220 16737449

    Patients

    Seq Age Sex Outcome Treatment
    1