BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4230681 · Received November 6, 2014

    Report

    Report Number
    2134265-2014-06868
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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

    SAME CASE AS MDR ID: 2134265-2014-06867. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. A PHYSICIAN IMPLANTED TWO PROMUS PREMIER¿ STENTS DURING A PERCUTANEOUS CORONARY INTERVENTION. ONE WAS A PROMUS PREMIER¿ 3.00X32MM AND THE OTHER WAS A PROMUS PREMIER¿ 3.00X12MM. WITHIN AN HOUR OF THE PROCEDURE, THE PATIENT DEVELOPED THROMBOSIS. THEY BROUGHT THE PATIENT BACK TO THE CATH LAB. THE PHYSICIAN DILATED THAT AREA AND PLACED INTRACORONARY INTEGRILIN. THEY ADMITTED THE PATIENT TO THE HOSPITAL FOR OVERNIGHT MONITORING. THE THROMBOSIS WAS RESOLVED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714326 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812300 0016763146

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R