BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1581991 · Received January 15, 2010

    Report

    Report Number
    2024168-2010-00075
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 21, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND PROMUS STENT (PART UNK, LOT UNK), INDICATED IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PATIENT EXPIRED IN ICU. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT TWO PROMUS STENTS WERE IMPLANTED. THE PATIENT WAS SENT TO ICU AND EXPIRED AN HOUR LATER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    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 UNK Death STENT: PROMUS (PART UNK, LOT UNK)