BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3132880 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03668
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    January 24, 2013
    Report Date
    July 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LAB DATA AND OTHER RELEVANT HISTORY UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. SAME CASE AS MDR ID# 2134265-2013-03667. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH STABLE ANGINA (BRAUNWALD CLASSIFICATION- UNKNOWN) AND MYOCARDIAL INFARCTION, AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS A DE NOVO LESION FOR ST ELEVATION MYOCARDIAL INFARCTION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS, WITH A LESION LENGTH OF 8 MM AND WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION#1 WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS ALSO A DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL WITH 50% STENOSIS, WITH A LESION LENGTH OF 14 MM AND WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #2 WAS TREAT WITH PREDILATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL 3 DAYS POST PROCEDURE. IN (B)(6) 2013, THE SUBJECT DIED.

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. SAME CASE AS MDR # 2134265-2013-03667. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH STABLE ANGINA (BRAUNWALD CLASSIFICATION- UNKNOWN) AND MYOCARDIAL INFARCTION, AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS A DE NOVO LESION FOR ST ELEVATION MYOCARDIAL INFARCTION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH 80% STENOSIS, WITH A LESION LENGTH OF 8 MM AND WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION#1 WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS ALSO A DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL WITH 50% STENOSIS, WITH A LESION LENGTH OF 14 MM AND WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. TARGET LESION #2 WAS TREAT WITH PREDILATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL 3 DAYS POST PROCEDURE. IN (B)(6) 2013, THE SUBJECT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236415 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911616250 14958785

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death