BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1656774 · Received April 8, 2010

    Report

    Report Number
    2024168-2010-00718
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 15, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINED IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE FIRST OTW PROMUS 3.5 X 23 MM (PART# 1009548-23B/LOT# 9102161) MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURE NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: EMBOLIZATION/DEATH. ONSET OF ADVERSE EVENT: DURING STENTING PROCEDURE. IT WAS REPORTED THAT THE INTERVENTION WAS ON A SAPHENOUS VEIN GRAFT (SVG) TO AN OBTUSE MARGINAL (OM). THE FIRST PROMUS STENT WAS DEPLOYED AND THE PATIENT'S RHYTHM SLOWED. A SECOND PROMUS STENT WAS DEPLOYED AND THE PATIENT LOST ALL PRESSURE. THE PATIENT COULD NOT BE REVIVED. THE PROCEDURE WAS ON THE ONLY VESSEL FEEDING THE LEFT VENTRICLE. REPORTEDLY, THE PATIENT'S GRAFTS WERE OVER 20 YEARS OLD AND HAD DISTAL EMBOLIZATION. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED. (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 9072261

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death OTW PROMUS 3.5 X 23 MM (PART# 1009548-23B| LOT# 9102161)