BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1972375 · Received January 25, 2011

    Report

    Report Number
    2953200-2011-00175
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 21, 2010
    Report Date
    October 28, 2013
    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

    (B)(4). EVALUATION, RESULTS: MYOCARDIAL INFARCTION, REVASCULARIZATION.

    Description of Event or Problem · 1

    APPROXIMATELY 60 MONTHS POST THE INDEX PROCEDURE THE PATIENT PASSED AWAY DUE TO RENAL INSUFFICIENCY. DEATH CLASSED AS NON CARDIAC. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    PT CARDIAC STATUS AT TIME OF PROCEDURE WAS SILENT ISCHEMIA. ONE ENDEAVOR RAPID EXCHANGE DRUG-ELUTING STENT WAS IMPLANTED TO THE DISTAL LAD. PT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN AND CLOPIDORGREL. PT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW UP STATES. AN ACUTE NON-STEMI IS REPORTED TO HAVE OCCURRED APPROX 2 YEARS 4.5 MONTHS POST INITIAL STENT IMPLANT. PT WAS REPORTED TO HAVE UNSTABLE ANGINA (SUDDEN CARDIAC ARREST ST-TROPO +). LOCATION OF THE INFARCTION WAS NON-DETERMINABLE. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED THE THE STUDY PROCEDURE. THREE DAYS POST MI EVENT, PT UNDERWENT A PTCA REVASCULARIZATION PROCEDURE. CLINICAL INDICATIONS FROM INTERVENTION WERE 'OBJECTIVE SIGNS OF ISCHEMIA AT REST (ECG CHANGES) OR DURING EXERCISE TEST (OR EQUIVALENT) PRESUMABLY RELATED TO THE TARGET VESSEL'. TWO ENDEAVOR SPRINT RAPID EXCHANGE DRUG ELUTING STENTS WERE IMPLANTED; ONE TO THE PROXIMAL LAD AND ONE TO THE MID LAD. IT IS REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT/PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000621440

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 24 HOURS PRIOR TO EVENT.| PT WAS ON CLOPIDOGREL/ TICLOPIDINE