BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2133350 · Received June 14, 2011

    Report

    Report Number
    9612164-2011-00569
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    December 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (MI AND DEATH).

    Description of Event or Problem · 1

    TWO LESIONS WERE TREATED DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED, ONE AT THE DISTAL RCA AND ONE AT THE RIGHT PDA. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YR, 1.5 YR AND 2 YR FOLLOW UPS. IT HAS BEEN REPORTED THAT APPROX 2 YRS POST INDEED PROCEDURE, THE PT SUFFERED AN MI. THE INVESTIGATOR HAS REPORTED THAT IT WAS AN ACUTE NON-STEMI, NON Q-WAVE MI WHICH DID NOT INVOLVE THE TARGET LESION. THE PT WAS TAKING ASPIRIN 24 HRS PRIOR TO THE EVENT. APPROX 4 DAYS POST THE MI EVENT, THE PT DIED. THE INVESTIGATOR HAS REPORTED THAT THE DEATH WAS A NON-SUDDEN CARDIAC DEATH WHICH WAS ASSOCIATED WITH AN MI, THERE WAS NO EVIDENCE OF STENT THROMBOSIS. EVENT REPORTED AS, "VF ARREST WITH A DOWN TIME OF 25 MINS, PT WAS TRANSFERRED TO ICU, FURTHER COMPLICATED WITH HYPOXIC BRAIN INJURY." (REF MFR # 9612164-2011-00570).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death ASPIRIN