BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2843276 · Received November 22, 2012

    Report

    Report Number
    9612164-2012-01690
    Event Type
    Death
    Date Received
    November 22, 2012
    Date of Event
    December 26, 2011
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (CVA/STROKE AND DEATH). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PREVIOUSLY REPORTED DEATH WAS A NON-CARDIAC DEATH RESULTING FROM INFECTION CAUSED BY ARTERIOSCLEROTIC OBLITERATION.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT STENT IMPLANTED IN THE R-PAV. APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A SUBARACHNOID HAEMORRHAGE. IT IS NOT ASSESSED IF THE EVENT WAS RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT DEATH OCCURRED APPROXIMATELY 38 MONTHS POST INDEX PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN. IT IS NOT ASSESSED IF THE EVENT WAS RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE LEFT MAIN TO LCX WAS TREATED DURING THE INDEX PROCEDURE AND NOT THE R-PAV AS INITIALLY REPORTED. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT REVASCULARIZATION OF LEFT MAIN TO LCX WITH POBA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death| R ASPIRIN AND CLOPIDOGREL