BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1696658 · Received May 21, 2010

    Report

    Report Number
    2953200-2010-00916
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    December 29, 2009
    Report Date
    April 23, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: CVA/STROKE AND DEATH.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE IMPLANTED, ONE IN THE MID LAD AND ONE IN THE DISTAL LCX. (MFR REPORT# 2953200-2010-00915) AT 1 MONTH, 6 MONTH AND 12 MONTH FOLLOW-UPS PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT IS REPORTED THAT SPONTANEOUS INTRACRANIAL BLEEDING / STROKE OCCURRED APPROXIMATELY 14 MONTHS FOLLOWING INDEX PROCEDURE. PT WAS ADMITTED FOR BRAINSTEM HEMORRHAGE. CT BRAIN SCAN REVEALED MASSIVE LEFT CEREBELLAR ICH WITH IVH AND HYDROCEPHALUS. IT IS REPORTED THAT THE PT EXPIRED TWO DAYS LATER. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENTS. IT WAS REPORTED THAT THE DEATH WAS NOT ASSOCIATED TO MI AND THERE WAS NO EVIDENCE OF STENT THROMBOSIS. AUTOPSY REPORT IS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death ASA 24HRS BEFORE EVENT| CLOPIDOGREL 24HRS BEFORE EVENT