BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2771683 · Received October 4, 2012

    Report

    Report Number
    9612164-2012-01482
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    July 3, 2012
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION-CONCLUSION - INHERENT RISK OF PROCEDURE (CVA/ STROKE).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT SUCCESSFULLY DEPLOYED AT RCA. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE PATIENT WAS ADMITTED TO HOSPITAL AFTER SUFFERING A STROKE, PATIENT WAS TREATED WITH MEDICATION. THE INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE.

    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 00044 YR Hospitalization| L ASA AND CLOPIDOGREL