BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3240321 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05004
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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. THE BATCH NUMBER IS UNKNOWN; THEREFORE, THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IN-STENT RESTENOSIS AND STENT DAMAGE OCCURRED. ON (B)(6) 2013, THE PATIENT RETURNED WITH A MODERATE IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM PERFORMED LAST (B)(6) 2012. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) EXTENDING TO THE SAPHENOUS VEIN GRAFT (SVG). THE PHYSICIAN THEN DECIDED TO PERFORM A PERCUTANEOUS CORONARY INTERVENTION AND UPON ADVANCING OF THE UNSPECIFIED GUIDE WIRE TO THE LESION, IT INTERACTED WITH THE IMPLANTED STENT RESULTING TO A LONGITUDINAL STENT COMPRESSION. THE PHYSICIAN THEN TREATED IT WITH A HIGH PRESSURE POST DILATION AND DEPLOYMENT OF AN UNSPECIFIED TAXUS LIBERTE STENT. DUE TO THE RESIDUAL STENT MATERIAL PRESENT IN THE AORTIC ROOT, PATIENT WILL BE IN A "LIFELONG" CLOPIDOGREL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339446 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention