BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2881749 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08135
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION 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 TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT CIRCUMFLEX ARTERY. THE 3.0 X 20 MM PROMUS ELEMENT STENT ENCOUNTERED RESISTANCE ADVANCING TO THE TARGET LESION. THE PROMUS ELEMENT STENT DISLODGED FROM THE BALLOON WHILE INSIDE THE LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN WAS UNSUCCESSFUL IN RETRIEVING THE PROMUS ELEMENT STENT. IT WAS NOTED THAT THE PROXIMAL END OF THE PROMUS ELEMENT STENT WAS DAMAGED. THE PHYSICIAN DEPLOYED THE PROMUS ELEMENT STENT FROM THE OSTIAL OF THE LEFT CIRCUMFLEX ARTERY TO THE PROXIMAL LEFT CIRCUMFLEX ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention