BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1369381 · Received April 24, 2009

    Report

    Report Number
    2024168-2009-00705
    Event Type
    Death
    Date Received
    April 24, 2009
    Date of Event
    October 6, 2008
    Report Date
    March 30, 2009
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: MYOCARDIAL INFRACTION; SUBSEQUENT DEATH. DEVICE ISSUE: NO MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT VIA A TRIAL, THE PATIENT HAD A PROMUS STENT IMPLANTED IN 2008; HOWEVER, TWO MONTHS LATER, THE PATIENT SUFFERED A MYOCARDIAL INFARCTION AND DIED. THE CAUSE OF DEATH WAS MYOCARDIAL INFRACTION, DEFINITELY RELATED TO THE STUDY DEVICE. THE PATIENT WAS TAKING ASPIRIN AND PLAVIX AT THE TIME OF THE EVENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR AS DISTRIBUTOR DISTRIBUTES PROMUS IN THE US AS ITS BRAND LABEL OF ABBOTT VASCULAR'S DRUG ELUTING STENT.

    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 44 YR Death| L| S