BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2172667 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00785
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    April 12, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEATH).

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE PROXIMAL LAD AND TWO OVERLAPPING IN THE MID RCA. SIX DAYS FOLLOWING THE INDEX PROCEDURE, THE PT WAS RE-HOSPITALIZED WITH CHEST PAIN, RENAL FAILURE AND MID ELEVATION OF TROPONIN. IT IS REPORTED THAT THE RENAL FAILURE HAD A POSSIBLE RELATIONSHIP WITH THE STUDY PROCEDURE. TWO DAYS LATER, THE PT WAS ADMITTED FOR A STAGED PROCEDURE AND HAD TWO NON-MEDTRONIC STENTS IMPLANTED IN THE PROXIMAL AND DISTAL LCX. THE PT DEVELOPED BRADYCARDIA DURING HOSPITALIZATION AND A DUAL CHAMBER PPM WAS INSERTED. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PT DEVELOPED CHEST PAIN AND WAS ADMITTED TO HOSPITAL. CATH. WAS DELAYED DUE TO ACUTE RENAL FAILURE. PT DEVELOPED SHORTNESS OF BREATH AND AN ECHO SHOWED PERICARDIAL TAMPONADE. KLEBSIELLA CYSTIS WAS DIAGNOSED. PERICARDIOCENTESIS WAS PERFORMED. PT WAS REPORTED TO HAVE RECOVERED WITH TREATMENT. APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, THE PT DIED SUDDENLY. CAUSE OF DEATH IS UNK. IT IS REPORTED THAT THE DEATH WAS POSSIBLY RELATED TO THE STUDY STENT. IT IS REPORTED THAT EMT WAS RECALLED AND CPR WAS STARTED AT HOME. PT WAS PRONOUNCED DEAD ON ARRIVAL AT HOSPITAL. ( REF MFR # 9612164-2011-00783, 9612164-2011-00784).

    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 68 YR Death| H| R CLOPIDOGREL| ASPIRIN