BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1080738 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00575
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 23, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - OTHER: (LACK OF INFO), (MYOCARDIAL INFARCION).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX STENT (3.00 X 12MM) WAS IMPLANTED AT THE PROXIMAL LAD AND 3 ENDEAVOR SPRINT RX STENTS (2.5 X 08MM, 2.5 X 24MM, 2.25 X 12MM) WERE IMPLANTED AT THE DISTAL LAD. (MFR REPORT # 2953200-2008-00575 - 00578). INVESTIGATOR HAS INDICATED THAT AN ACUTE NON-STEMI WAS SUFFERED ON THE SAME DAY AS IMPLANT. THE PT WAS ASYMPTOMATIC AT THE 30 DAY FOLLOW-UP STAGE. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000531448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK