BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1725461 · Received June 11, 2010

    Report

    Report Number
    2024168-2010-01173
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 5, 2009
    Report Date
    May 19, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. TIME OF ADVERSE EVENT: APPROXIMATELY 7 MONTHS POST STENTING PROCEDURE. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS ON (B) (6) 2008 IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS PROXIMAL CX. THE PATIENT WAS DISCHARGED TWO DAYS POST STENTING PROCEDURE ON ASPIRIN AND PLAVIX. REPORTEDLY, THE PATIENT EXPIRED ON (B) (6) 2009 DUE TO HEART FAILURE. THE PATIENT REMAINED TAKING ASPIRIN AND PLAVIX AT THE TIME OF DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS UNRELATED TO THE STUDY DEVICE; HOWEVER, THE MEDICAL MONITOR REVIEWED THIS A CARDIAC DEATH AND RELATION TO THE REGISTRY STENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE, (B) (4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 8050841

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death