BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4143598 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05954
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MID RIGHT CORONARY ARTERY. A 4.00MM X 38MM PROMUS PREMIER¿ STENT WAS ADVANCED TO THE LESION BUT THE STENT DETACHED FROM THE STENT DELIVERY SYSTEM. THE DETACHED STENT DID NOT EMBOLIZE AND WAS RETRIEVED SUCCESSFULLY USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623828 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952838400 16502630

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention