BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2820085 · Received November 6, 2012

    Report

    Report Number
    9612164-2012-01622
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    July 15, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE LAD AND 1ST DIAGONAL BRANCH DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 20 MONTHS POST THE INDEX PROCEDURE THE PATIENT DEATH OCCURRED; CAUSE OF DEATH UNKNOWN. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI WHICH RESULTED IN THE PATIENT DEATH. THE INVESTIGATOR HAS INDICATED THAT THE MI WAS POSSIBLY RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001019758

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death ASPIRIN AND CLOPIDOGREL