BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2962241 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00619
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT WAS NOT RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER ERROR AS THE DEVICE WAS USED IN A SAPHENOUS VEIN GRAFT WHICH IS CONTRAINDICATED IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-00617. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE A MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. A 3.0X28MM PROMUS ELEMENT PLUS STENT ALONG WITH A 2.50X32MM PROMUS ELEMENT PLUS STENT WERE IMPLANTED AND OVERLAPPING IN THE MILDLY CALCIFIED SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT POSTERIOR DESCENDING ARTERY (PDA). THE STENTS WERE POST DILATED WITH AN UNSPECIFIED BALLOON AND IT WAS NOTED THAT THE STENTS WERE WELL APPOSED IN THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND DUAL ANTIPLATELET MEDICATION OF PLAVIX AND ASA WAS GIVEN. SIX DAYS LATER IT WAS NOTED THAT THE PATIENT CONTINUED TO HAVE CHEST PAIN AND SHORTNESS OF BREATH AND PRESENTED WITH A NON ST ELEVATED MYOCARDIAL INFARCTION AND STENT THROMBOSIS. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB WHERE IT WAS ATTEMPTED TO ASPIRATE THE OCCLUDED VESSEL; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS STABLE AND THE PROCEDURE WAS ENDED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64482 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428300 15594066

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 2.50X32MM PROMUS ELEMENT PLUS STENT