BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT

    MDR report key: 7266344 · Received February 13, 2018

    Report

    Report Number
    2134265-2018-01417
    Event Type
    Death
    Date Received
    February 13, 2018
    Date of Event
    July 19, 2017
    Report Date
    October 19, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    PROMUS ELEMENT CHINA CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT WAS ENROLLED INTO THE PROMUS ELEMENT CHINA STUDY ON (B)(6) 2013 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. ON (B)(6) 2015, 953 DAYS POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN IN-STENT RESTENOSIS IN PROXIMAL RIGHT CORONARY ARTERY (RCA) AN WAS HOSPITALIZED ON THE SAME DAY. MEDICATIONS WERE ADMINISTERED TO TREAT THE EVENT. ON (B)(6) 2015, THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2017, THE PATIENT DIED. THE CAUSE OF DEATH OF IS UNEXPLAINED. IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH WAS CEREBRAL HEMORRHAGE.

    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. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY WITH 80% STENOSIS AND WAS 22 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION WITH PLACEMENT OF 3.50 X 24 MM (B)(6) STUDY STENT. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE PATIENT DIED. NO ACTIONS WERE TAKEN WITH REGARDS TO THIS EVENT. THE CAUSE OF DEATH OF IS UNEXPLAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109677 PROMUS ELEMENT STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 9309 0015385241

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death