BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1053177 · Received May 28, 2008

    Report

    Report Number
    2953200-2008-00368
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    June 18, 2011
    Report Date
    April 30, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: MYOCARDIAL INFARCTION; LACK OF INFORMATION. CONCLUSION: REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    FOUR ENDEAVOUR STENTS WERE IMPLANTED APPROXIMATELY 8 WEEKS AGO FOR TREATMENT OF 4 LESIONS. THE PATIENT SUFFERED A MYOCARDIAL INFARCTION ON SAME DAY OF THE PROCEDURE (ACUTE NON-STEMI). THE FIRST TWO LESIONS TREATED WERE LOCATED IN THE LAD (PROXIMAL AND MID). ONE ENDEAVOR STENT WAS IMPLANTED TO THE PROXIMAL LAD (3.0 X 12MM STENT) (SEE MFR # 2953200-2008-0366) AND ONE ENDEAVOR STENT WAS IMPLANTED TO THE MID LAD (2.75 X 24MM STENT) (SEE MFR # 2953200-2008-0367) - ABUTTING STENTS. TWO ENDEAVOR STENTS WERE ALSO IMPLANTED TO THE 1ST OBTUSE MARGINAL (2.75 X 24MM & 3.0 X 18MM STENTS) (SEE MFR # 2953200-2008-0369) - ABUTTING STENTS. IT WAS ALSO PLANNED TO TREAT A FURTHER LESION (LOCATED IN PLSA) WITHIN 6 WEEKS FROM THE INITIAL IMPLANT (STAGED PROCEDURE). THE PATIENT SUFFERED A MYOCARDIAL INFARCTION ON THE SAME DAY OF IMPLANT (ACUTE NON-STEMI). THE PATIENT WAS TAKING ASA AND CLOPIDOGREL/TICLOPIDINE 24 HOURS PRIOR TO THE EVENT. IT IS UNKNOWN WHETHER THE TARGET LESIONS WERE INVOLVED IN THE MI. THE LOCATION OF THE INFARCT WAS BOTH POSTERIOR AND LATERAL. THE INVESTIGATOR ASSESSED THE EVENT AS A NON-Q-WAVE MI. THE INVESTIGATOR REPORTED THAT THE PATIENT WAS ASYMPTOMATIC POST PROCEDURE. NST MI, NO ANGINA, INFEROLATERAL ST DEPRESSION, TROPO +. PLEASE NOTE THAT THIS DEVIC IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000352063

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Male Required Intervention CLOPIDOGREL/TICLOPIDINE 24 HOURS PRIOR TO EVENT.| UNK.