BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2851793 · Received November 30, 2012

    Report

    Report Number
    9612164-2012-01723
    Event Type
    Death
    Date Received
    November 30, 2012
    Date of Event
    June 15, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LCX. A DISSECTION WAS NOTED, THEREFORE, A 3.5 X18 DIAMETER ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LCX, OVERLAPPING, AS TREATMENT FOR THE COMPLICATION/ DISSECTION/ BAILOUT. IT IS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 55 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000532615

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| H| R