BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1820551 · Received August 31, 2010

    Report

    Report Number
    2134265-2010-03740
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH PAIN AND POST A GRAFT PROCEDURE PERFORMED ON THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ANGIOPLASTY WAS PERFORMED IN THE CIRCUMFLEX (CX) AND LAD FROM THE LEFT MAIN STEM. ONE UNSPECIFIED STENT WAS SUCCESSFULLY IMPLANTED IN THE CX. THEN PRE-DILATATION WITH AN UNSPECIFIED BALLOON WAS PERFORMED. NEXT, A PROMUS ELEMENT 3.0X12MM STENT WAS ADVANCED BUT WOULD NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT AND NO ANOMALIES WERE OBSERVED UPON INSPECTION. THE PHYSICIAN PRE-DILATED THE LESION AGAIN AND ATTEMPTED TO ADVANCE THE STENT A SECOND TIME BUT IT STILL WOULD NOT CROSS THE LESION. THE SDS WAS AGAIN REMOVED FROM THE PATIENT AND UPON INSPECTING THE DEVICE IT WAS NOTED THERE WAS NO STENT ON THE BALLOON. THE PHYSICIAN IS CONFIDENT THE STENT IS NOT IN THE PATIENT AND CAME OFF THE STENT OUTSIDE THE PATIENT SOMEHOW. NO FURTHER ACTION WAS TAKEN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312300 13406265

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR