BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 6129845 · Received November 28, 2016

    Report

    Report Number
    2134265-2016-10605
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    March 18, 2016
    Report Date
    November 2, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    UDI-DI
    08714729807766
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED 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

    DESCRIBE EVENT OR PROBLEM , PATIENT CODES AND DEVICE CODES UPDATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASED AS MDR ID: 2134265-2016-10604. PROMUS ELEMENT¿ PLUS CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 90% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.00 MM. THE TARGET LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF 2.25 X 12 MM AND 2.25 X 16 MM PROMUS ELEMENT¿ PLUS STENTS WITH 0% RESIDUAL STENOSIS. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT STENT THROMBOSIS OCCURRED AS ADJUDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780198 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416220 0015126703 08714729807766

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death