BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2170034 · Received July 15, 2011

    Report

    Report Number
    9612164-2011-00728
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (MI, INFECTION).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PT HAD 3 ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED TO THE MID RCA. ON THE SAME DAY AS THE INDEX PROCEDURE THE PT WAS RE-ADMITTED TO HOSPITAL FOR ST DEPRESSION. AND A STENT WAS PLACED IN THE PROXIMAL CIRCUMFERENCE. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE, STUDY PROCEDURE OR STUDY DRUG. PT RECOVERED WITH TREATMENT. APPROX 4.5 MONTHS POST INDEX PROCEDURE, IT IS REPORTED THAT THE PT SUFFERED AN MI. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE, STUDY PROCEDURE OR STUDY DRUG. APPROX 4 DAYS LATER, IT IS REPORTED THAT THE PT EXPIRED. CAUSE OF DEATH WAS ASSESSED TO BE DUE TO AN INFECTION. SUBJECT HAD PRESENTED TO HOSPITAL WITH ABDOMINAL PAIN, NAUSEA, VOMITING, AND LOW-GRADE TEMPERATURE OF 100.8. HE HAD A WHITE BLOOD CELL COUNT OF 26,000. PT WAS INITIALLY TREATED FOR WHAT WAS THOUGHT WAS A UTI AND UROSEPSIS. PT STOOL BECAME LIQUID, AND INFECTIOUS DISEASE WAS CONSULTED. TREATMENT WITH VANCOMYCIN THERAPY INITIATED. PT WAS FOUND UNRESPONSIVE WITH 02 SATURATIONS IN THE 70'S AND BLOOD GLUCOSE OF 20. RESPECTING DNR WISHES SUBJECT EXPIRED AND WAS PRONOUNCED. IT WAS REPORTED THAT THE DEATH WAS NOT ASSOCIATED WITH A MI AND THERE WAS NO EVIDENCE OF STENT THROMBOSIS. (REF MFR # 9612164201100729 AND 9612164201100730).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death CLOPIDOGREL| ASPIRIN