BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3180084 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04210
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2013-04209. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL AND CIRCUMFLEX ARTERY. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A PROMUS ELEMENT PLUS STENT. A SECOND PROMUS ELEMENT PLUS STENT WAS IMPLANTED AT THE CIRCUMFLEX ARTERY TO THE OBTUSE MARGINAL BRANCH. UPON ATTEMPTING TO POST-DILATE THE FIRST IMPLANTED STENT, THE STENT STRUT WAS COMPRESSED. UPON POST-DILATING THE SECOND IMPLANTED PROXIMAL STENT, THE STENT STRUT WAS COMPRESSED AS WELL. NO ADDITIONAL STENTING WAS DONE OVER COMPRESSED AREA. THE PROCEDURE WAS COMPLETED AND THE NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279904 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other