BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1712898 · Received June 4, 2010

    Report

    Report Number
    2024168-2010-01114
    Event Type
    Death
    Date Received
    June 4, 2010
    Date of Event
    March 13, 2010
    Report Date
    May 11, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE PROMUS 2.5 X 23 MM (PART# 1009545-23B, LOT#9061961) INDICATED IS BEING FILED UNDER THE SAME MEDWATCH MFR NUMBER. THE STENTS REMAIN IN THE PT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. TIME OF ADVERSE EVENT: APPROXIMATELY 48 HOURS POST PROCEDURE. IT WAS REPORTED THAT ON (B) (6) 2010, THE PT UNDERWENT A CORONARY ARTERY STENTING PROCEDURE WITH IMPLANTATION OF TWO PROMUS STENTS, ONE IN THE MID RIGHT CORONARY ARTERY AND ONE IN THE MID LEFT ANTERIOR DESCENDING ARTERY. ON (B) (6) 2010, THE PT BEGAN CLOPIDOGREL 75MG AND WAS DISCHARGED FROM THE HOSPITAL. ON (B) (6) 2010, THE PT EXPERIENCED CHEST PAIN AND CHANGE IN RESPONSIVENESS. EMS WAS CALLED AND THE PT WAS SEVERELY BRADYCARDIC, HYPER RESPONSIVE, DELIRIOUS, EXTREMITIES WERE FLACCID AND PAPILLARY RESPONSE TO LIGHT WAS SLUGGISH. THE PT WAS ADMITTED TO THE HOSPITAL AND A CT SCAN REVEALED A MASSIVE ACUTE RIGHT CEREBRAL HEMISPHERIC HEMORRHAGE. NO TREATMENT WAS GIVEN FOR THE BRADYCARDIA OR THE HEMORRHAGE. CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS, EKG REVEALED SINUS TACHYCARDIA WITH NON-SPECIFIC ST AND T WAVE ABNORMALITIES. THE PT WAS INTUBATED AND SEDATED. THE FAMILY ELECTED TO WITHDRAW LIFE SUPPORT AND THE PT EXPIRED ON (B) (6) 2010 AT 20:58. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS REPORTED AS INTRACRANIAL HEMORRHAGE. NO ADDITIONAL INFORMATION IS AVAILABLE. (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 9071361

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death PROMUS 2.5 X 23MM (PART# 1009545-23B, LOT#9061961)