BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3200493 · Received July 1, 2013

    Report

    Report Number
    2134265-2013-04614
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    July 18, 2012
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2013-04613. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, VASOSPASM OCCURRED. THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION NO. 1 WAS A DE NOVO LESION LOCATED IN THE FIRST OBTUSE MARGINAL (OM) WITH 99% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25MM X 16 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION NO. 2 WAS A DE NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO FIRST OBTUSE MARGINAL (OM) WITH 70% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.00MM X 20 MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. POST DEPLOYMENT OF THE SECOND STENT, THERE WAS SOME SPASM NOTED WHICH WAS TREATED WITH NITROGLYCERINE. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299345 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420300 15224132

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention