BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3800355 · Received May 8, 2014

    Report

    Report Number
    2134265-2014-02694
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 14, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 THROMBOSIS OCCURRED. A PROMUS PREMIER STENT WAS IMPLANTED IN AN UNKNOWN LESION AND AN UNSPECIFIED AMOUNT OF TIME LATER ACUTE STENT THROMBOSIS OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD ANOTHER UNSPECIFIED DIAGNOSIS, WHICH WAS A CRITICAL CONDITION OUTSIDE OF CORONARIES, THAT COULD HAVE HAD AN EFFECT ON THE STENT THROMBOSIS THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277102 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 Other