BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2920063 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00071
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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 A VESSEL DISSECTION OCCURRED. THE DE NOVO LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN IMPLANTED A 3.00X20MM PROMUS ELEMENT STENT IN THE TARGET LESION AND A DISSECTION WAS NOTED DISTAL TO THE IMPLANTED STENT. THE PHYSICIAN TREATED THE DISSECTION BY IMPLANTING ANOTHER PROMUS ELEMENT STENT. THE PROCEDURE WAS COMPLETED BY IMPLANTING A THIRD PROMUS ELEMENT STENT IN THE LEFT ANTERIOR DESCENDING ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25562 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention