BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2090029 · Received May 16, 2011

    Report

    Report Number
    2134265-2011-01664
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 80% STENOSED, 2.75X15MM, ECCENTRIC AND DE NOVO TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.5X15MM SEMICOMPLIANT BALLOON LEAVING 30% RESIDUAL STENOSIS. THE 3.00X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA AND IT WAS NOTED THAT THE STENT MOVED ON THE BALLOON WHILE TRYING TO POSITION THE DEVICE. AN ATTEMPT WAS MADE TO WITHDRAW THE DEVICE INTO THE 5 FRENCH GUIDE CATHETER AS ONE UNIT HOWEVER THE STENT CAME OFF OF THE BALLOON AND REMAINS IN THE RIGHT RADIAL ARTERY. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. 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 H7493911316300 14150695

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other