BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1982479 · Received February 7, 2011

    Report

    Report Number
    2953200-2011-00296
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    October 27, 2010
    Report Date
    July 2, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE DISTAL RCA AND ONE IN THE 1ST DIAGONAL BRANCH. IT IS REPORTED THAT THE PT WAS ADMITTED TO HOSPITAL FOR CONGESTIVE HEART FAILURE APPROX 2.5 MONTHS POST INDEX PROCEDURE. PT REC'D MEDICATION, WAS MONITORED AND DISCHARGED HOME THE NEXT DAY. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR STUDY PROCEDURE. THE PT ARRIVED AT THE HOSPITAL APPROX 3 MONTHS POST INDEX PROCEDURE SUFFERING FROM NAUSEA, VOMITING, SHORTNESS OF BREATH, EKG CHANGES AND INCREASED CARDIAC ENZYMES. PT'S CONGESTIVE HEART FAILURE WORSENED, PT COLLAPSED AND WAS RESUSCITATED AND PLACED ON VENTILATOR. ECHOCARDIOGRAM WAS DONE AND SHOWED QUESTIONABLE LUMBAR THROMBUS IN INFRACTION AREA. MILD LEFT VENTRICULAR DYSFUNCTION OF 45%. IT IS REPORTED THAT THE PT SUFFERED AN ACUTE NON-STEMI, NON Q WAVE INFERIOR INFRACTION. IT IS REPORTED THAT THE PT EXPIRED THE NEXT DAY. IT IS REPORTED THAT THE CAUSE OF DEATH WAS CARDIAC ISCHEMIA. (REF MFR # 2953200-2011-00295).

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED MI HAS BEEN UPDATED TO ACUTE STEMI AND THE INVESTIGATOR HAS INDICATED THE MI WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death