BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2914769 · Received January 14, 2013

    Report

    Report Number
    2134265-2012-08489
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGEMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED AND MILDLY TORTUOUS VESSEL. THE PHYSICIAN IMPLANTED TWO STENTS IN THE TARGET LESION BEFORE ADVANCING A 3.00X32 MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS). HOWEVER, THE SDS WAS UNABLE TO CROSS THE IMPLANTED STENTS. UPON REMOVAL THE SDS IT WAS NOTICED THAT THE STENT HAS DISLODGED INSIDE THE IMPLANTED STENTS. THE PHYSICIAN INFLATED A 1.5 MM EMERGE BALLOON CATHETER AT 20 ATMS AND DEPLOYED THE DISLODGED STENT. THEN A 3.0 MM EMERGE BALLOON CATHETER WAS USED FOR ADDITIONAL DILATION OF THE STENT. THE PROCEDURE WAS COMPLETED WITH AN ANGIOGRAM. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20884 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911432300 15142732

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention