BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2904222 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08308
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 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 A COMBINATION PRODUCT. AGE AT TIME OF EVENT: (B)(6). 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 DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED FOLLOWING DEPLOYMENT. THE TARGET LESION BEING TREATED WAS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) TO THE POSTERIOR DESCENDING ARTERY (PDA). A 3.50X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DEPLOYED IN THE PDA. A 3.50X24MM PROMUS ELEMENT SDS WAS THEN ADVANCED TO THE RCA AND DEPLOYED OVERLAPPING THE PREVIOUSLY PLACED STENT. AN INTRAVASCULAR ULTRASOUND CATHETER WAS THEN ADVANCED AND COULD NOT CROSS THE LESION. A 4.50X15MM QUANTUM APEX BALLOON CATHETER WAS THEN ADVANCED FOR POST-DILATION OF THE 3.50X24MM PROMUS ELEMENT STENT AND SOME OF THE STRUTS SEEMED ENLARGED. THE QUANTUM APEX BALLOON WAS INFLATED ABOVE NOMINAL PRESSURE. AN UNSPECIFIED STENT WAS THEN ADVANCED THROUGH A MICROCATHETER AND COULD NOT CROSS THE OVERLAPPING REGION OF THE DEPLOYED STENTS. ANOTHER ROUND OF POST-DILATION WAS PERFORMED WITH THE 4.50X15MM QUANTUM APEX BALLOON AND A STRUT OF THE 3.50X24MM PROMUS ELEMENT STENT SEEMED ENLARGED OR DEFORMED. THE MICROCATHETER WAS ADVANCED TO THE PDA AND A 3.50X30MM NON-BSC STENT WAS THEN ADVANCED AND DEPLOYED OVERLAPPING THE DAMAGED STRUT OF THE 3.50X24MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11650 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention