BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2223803 · Received August 18, 2011

    Report

    Report Number
    9612164-2011-00970
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    July 22, 2011
    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

    (B)(4). EVALUATION, RESULTS: ROOT CAUSE OF THE MI COULD NOT BE DETERMINED. FAILURE OF THE USER TO VERIFY THE PRODUCT EXPIRY PRIOR TO USE OF PRODUCT. MYOCARDIAL INFARCTION. DEVICE NOT RECEIVED FOR EVALUATION. EVALUATION, CONCLUSION: FAILURE OF THE USER TO VERIFY THE PRODUCT EXPIRY PRIOR TO USE OF PRODUCT.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RX DRUG ELUTING STENTS WERE IMPLANTED DURING THE INDEX PROCEDURE ONE IN THE CIRCUMFLEX ARTERY AND ONE IN THE MID CIRCUMFLEX. ON THE SAME DATE AS THE INDEX PROCEDURE, THE PATIENT IS REPORTED TO HAVE SUFFERED AN MI. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE TARGET VESSEL, NOT RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE STUDY PROCEDURE. PATIENT HAD NO CHANGE IN ANGINA STATUS AT 30 DAY, 3 MONTH AND 6 MONTH FOLLOW-UPS. THE ENDEAVOR SPRINT RX STENT IMPLANTED IN THE MID CIRCUMFLEX WAS IMPLANTED 17 DAYS BEYOND ITS EXPIRATION DATE. (REF MFR # 9612164-2011-00969).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND ENSP30015X 0000899496

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization CLOPIDOGREL| ASA| HEPARIN| ACE INHIBITOR| BETA| INSULIN