BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1964120 · Received January 12, 2011

    Report

    Report Number
    2953200-2011-00068
    Event Type
    Death
    Date Received
    January 12, 2011
    Date of Event
    January 1, 2009
    Report Date
    December 13, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. PT WAS DISCHARGED TWO WEEKS POST INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL. PT CARDIAC STATUS AT 30 DAY F/U WAS STABLE ANGINA. (REF. MFR 2953200-2011-00069). APPROX 6.5 WEEKS POST INDEX POST INDEX PROCEDURE REVASCULARIZATION (PTCA) OF THE PROXIMAL LCX WITH STENTING WAS PERFORMED. INDICATION FOR SURGERY WAS POSITIVE HISTORY OR RECURRENT ANGINA PECTORIS PRESUMABLY RELATED TO THE TARGET VESSEL. THE EVENT WAS CONSIDERED NOT LIFE THREATENING. ONE ENDEAVOR SPRINT RAPID EXCHANGE DRUG-ELUTING STENT WAS IMPLANTED TO THE PROXIMAL LCX. THIS WAS CLASSIFIED AS A NON-TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY STENT/ PROCEDURE. APPROX 10.5 MONTHS POST INDEX PROCEDURE THE PT SUFFERED A NON SUDDEN CARDIAC DEATH. PT WAS HOSPITALIZED WITH DYSPNOEA AND WEAK CONDITION. INCREASING PLEURAL EFFUSION. WORSENING OF CONDITION REANIMATION AND EXITUS LETALIS. NO AUTOPSY REPORT AVAILABLE. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY STENT/ PROCEDURE. PT WAS TAKING ASPIRIN AND CLOPIDOGREL/TICLOPIDINE PRIOR TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000535564

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 24 HOURS BEFORE THE EVENT| CLOPIDOGREL/ TICLOPIDINE| ASPIRIN