BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6104758 · Received November 15, 2016

    Report

    Report Number
    2134265-2016-10141
    Event Type
    Death
    Date Received
    November 15, 2016
    Date of Event
    March 17, 2016
    Report Date
    October 21, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #: 2134265-2016-10143. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2014, THE PATIENT WAS PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. ON SAME DAY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND WAS 50MM LONG WITH REFERENCE VESSEL DIAMETER OF 3.5MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 38 MM AND 3.50 X 16 MM PROMUS ELEMENT STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE PATIENT WAS DISCHARGE ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH CORONARY HEART DISEASE AND METASTATIC CARCINOMA OF BONE MARROW. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE MANAGEMENT OF THE EVENT. IN (B)(6) 2016, THE PATIENT WAS PRONOUNCED DEAD. THE PRIMARY CAUSE OF DEATH WAS NOTED TO BE CORONARY HEART DISEASE, METASTATIC CARCINOMA OF THE BONE MARROW.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PRIMARY CAUSE OF DEATH WAS ONLY METASTATIC CARCINOMA OF BONE MARROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752761 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316350 16506662

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death