BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3605358 · Received February 4, 2014

    Report

    Report Number
    2134265-2014-00298
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BALLOON WITHDRAWAL RESISTANCE OCCURRED. THE LESION WAS LOCATED IN THE 90% STENOSED, SEVERELY CALCIFIED, MODERATELY STENOSED MID DIAGONAL (DIAG). THE VESSEL DIAMETER WAS 2.25-2.5MM. THE LESION WAS PREDILATED USING A 2.0X8MM EMERGE BALLOON CATHETER. A 2.25X12MM PROMUS PREMIER DRUG ELUTING STENT WAS DEPLOYED IN THE MID DIAG AT 16ATM FOR 26 SECONDS. HOWEVER, FOLLOWING DEPLOYMENT OF THE STENT THE BALLOON WAS "STICKING" . THE FIRST ATTEMPT TO REMOVE THE BALLOON SUCKED THE GUIDE FURTHER INTO THE VESSEL. THE BALLOON WAS "REPREPPED" AND SHORT BRISK TUGGING REMOVED THE BALLOON. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72297 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812220 16389455

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR