BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4182099 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06208
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-06211. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG). THE ARTERY HAD A FULL METAL JACKET WITH UNSPECIFIED IMPLANTED STENTS ALL THE WAY DOWN THE ENTIRE ARTERY. THE STENT HAS TO GO THROUGH THE PREVIOUSLY PLACED STENTS TO REACH THE TARGET LESION. A 4.00MMX20MM PROMUS PREMIER¿ STENT WAS ADVANCED AND WHILE TRYING TO DELIVER THE STENT IT GOT DEFORMED. THE PHYSICIAN TRIED USING 4.00MMX16MM PROMUS PREMIER¿ STENT AND THE SAME THING HAPPENED, THE DEVICE GOT CAUGHT ON SOMETHING AND DEFORMING THE STENT. THE PROCEDURE WAS COMPLETED BY BALLOONING THE LESION USING AN EMERGE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660973 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952820400 16590161

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR