BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1843935 · Received September 21, 2010

    Report

    Report Number
    2024168-2010-01968
    Event Type
    Death
    Date Received
    September 21, 2010
    Date of Event
    March 22, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PT UNDERWENT THE INDEX PROCEDURE, DUE TO ACUTE CORONARY SYNDROME AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI). A PROMUS 4.0 X 15 STENT WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA). POST PROCEDURE RESIDUAL STENOSIS WAS 0% DIAMETER STENOSIS WITH A POST PROCEDURE TIMI I FLOW. ON (B)(6) 2010, THE PT WAS DISCHARGED FROM INDEX HOSPITALIZATION. HOWEVER, ON (B)(6) 2010, DURING A 6 MONTH FOLLOW UP CALL, THE SITE LEARNED THAT THE PT HAD A FATAL CARDIAC ARREST THAT OCCURRED ON (B)(6) 2010. THE PT WAS REPORTED TO HAVE BEEN FOUND PULSELESS ON THE SIDE OF THE ROAD AND WAS BROUGHT TO THE EMERGENCY ROOM IN FULL ARREST AND SUBSEQUENTLY, A PT DEATH OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death