BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1222405 · Received November 5, 2008

    Report

    Report Number
    2953200-2008-01006
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 11, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (STROKE).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT STENTS WERE IMPLANTED (MFR REPORT # 2953200-2008-01007) IN THE MID LAD. AN ISCHEMIC STROKE IS REPORTED TO HAVE OCCURRED FOUR MOS POST INITIAL STENT IMPLANT. PT WAS REPORTED TO BY ASYMPTOMATIC AT 30 DAY AND 6 MONTH FOLLOW UP. INVESTIGATOR HAS REPORTED THAT IT IS NOT ASSESSABLE WHETHER EVENT WAS RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000562510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention