BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3950880 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04220
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 DAMAGE OCCURRED. THE TARGET LESION BEING TREATED IS LOCATED IN THE SEVERELY TORTUOUS DISTAL LEFT CIRCUMFLEX (LCX). AFTER AN UNSPECIFIED GUIDEWIRE CROSSED THE LESION, ANOTHER UNSPECIFIED GUIDEWIRE WAS USED TO PROTECT THE SIDE BRANCH. AFTER PRE IVUS WAS PERFORMED, A 20 X 2.50 PROMUS PREMIER¿ STENT WAS DELIVERED INTO THE LESION WITHOUT PREDILATATION. WHEN THE STENT WENT OUT OF THE GUIDING CATHETER, STRONG RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE DISTAL EDGE OF THE STENT WAS DAMAGED/SQUASHED. THE PROCEDURE WAS COMPLETED WITH A 2.5 X 18 MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428752 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925120250 16834218

    Patients

    Seq Age Sex Outcome Treatment
    1