BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1367605 · Received April 17, 2009

    Report

    Report Number
    2953200-2009-00479
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    April 16, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, SECONDARY INTERVENTION.- RESULTS: (DISSECTION).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LCX TO TREAT THE TARGET LESION AND ONE FURTHER STENT WAS IMPLANTED, ABUTTING TO THE PREVIOUSLY IMPLANTED STENT, TO TREAT A COMPLICATION/DISSECTION/BAILOUT. THE PT WAS ASYMPTOMATIC AT 30 DAY FOLLOW-UP. INVESTIGATOR HAS REPORTED THAT IT IS NOT ASSESSABLE WHETHER THE EVENT WAS RELATED TO STUDY STENT.

    Description of Event or Problem · 1

    CABG REVASCULARIZATION OF THE OM AND LAD (NTV) WAS CARRIED OUT APPROXIMATELY 43 MONTHS POST INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000700279

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention PT WAS TAKING ASPIRIN AND CLOPIDOGREL 24 HRS PRIOR| TO EVENT.