BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3091735 · Received May 3, 2013

    Report

    Report Number
    9612164-2013-00507
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    October 30, 2012
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PREVIOUSLY REPORTED STROKE, WAS TREATED WITH MEDICATION. PLAVIX WAS ALSO RESTARTED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD FOUR ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED ONE IN THE RCA AND THREE IN THE OBTUSE MARGINAL. APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, THE PATIENT SUFFERED A STROKE. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT WAS LEFT WITH PERMANENT IMPAIRMENT AND IS CONTINUING WITHOUT TREATMENT. THE PATIENT WAS TAKING ASPIRIN PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195146 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR ASPIRIN