BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3881699 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03840
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.:  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 VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY. A 3.00X38MM PROMUS ELEMENT¿ PLUS STENT WAS SELECTED TO TREAT THE TARGET LESION. WHILE INFLATING THE BALLOON OF THE DELIVERY SYSTEM, DISSECTION WAS NOTED IN THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH A 2.75X16MM PROMUS ELEMENT PLUS STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357044 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438300 16458109

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention