BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER¿

    MDR report key: 6081457 · Received November 7, 2016

    Report

    Report Number
    2134265-2016-09736
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    April 20, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 VIA FACILITY MEDWATCH # (B)(4) THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. A PROMUS PREMIERE DRUG-ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, THE STENT WAS BENT ON THE BALLOON. WHILE ATTEMPTING TO REMOVE THE CATHETER WITH THE UNDEPLOYED STENT FROM THE GUIDEWIRE, THE STENT BECAME STUCK ON THE COPILOT DEVICE AND CAME OFF THE BALLOON. THE STENT NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732958 PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 79