BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2863082 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07463
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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, STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS CIRCUMFLEX (LCX) ARTERY. THE PHYSICIAN PLACED A 2.75 X 38MM PROMUS ELEMENT STENT IN THE PROXIMAL LCX. A 2.5 X 16MM PROMUS ELEMENT PLUS STENT WAS ADVANCED TO THE LESION BUT COULD NOT CROSS THE PREVIOUSLY PLACED STENT. DURING A SECOND ATTEMPT TO CROSS THE 2.5 X 16MM STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN USED A SNARE TO REMOVED THE DISLODGED STENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416250

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention