BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2111709 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01933
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    February 4, 2010
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY, AFTER THE BIFURCATION OF THE POSTERIOR INTERVENTRICULAR ARTERY (IVP) AND THE POSTEROLATERAL ARTERY (PL). THE LESION WAS PREDILATED WITH MULTIPLE BALLOONS INCLUDING A 1.5X20 MAVERICK BALLOON AND 2.5X20 NON-BSC BALLOON. NEXT, A 2.5X28MM PROMUS ELEMENT STENT WAS DEPLOYED AT 14ATMS/10SEC. IMMEDIATELY AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN FELT THAT IT WAS UNDER EXPANDED AND DECIDED TO POST DILATE USING A KISSING BALLOON 2.5X20MM NON-BSC BALLOON (10ATMS/10SEC) AND 3.5X15MM QUANTUM (8ATM/10SEC). CONCERTINA OF THE STENT WAS OBSERVED AFTER POST DILATATION. AN NON-BSC GUIDE CATHETER WAS USED TO IMAGE THE VESSEL, HOWEVER, IT DID NOT CONTRIBUTE TO THE CONCERTINED STENT. NO ADDITIONAL INTERVENTION WAS PERFORMED DUE TO THE ALC. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 0013038024

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 3.5X15MM QUANTUM| EAGLE EYE GUIDE CATHETER| 2.5X20 SPRINTER BALLOON.| 1.5X20 MAVERICK BALLOON