BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2141114 · Received June 21, 2011

    Report

    Report Number
    9612164-2011-00611
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    August 26, 2008
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (MYOCARDIAL INFARCTION).

    Description of Event or Problem · 1

    ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED AT THE DISTAL LAD, ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED AT THE RIGHT POSTERIOR DESCENDING ARTERY AND TWO ENDEAVOR RX-DRUG ELUTING STENTS WERE IMPLANTED, OVERLAPPING, AT THE MID RCA. FOLLOWING REVIEW BY THE CLINICAL EVENTS COMMITTEE, IT WAS ADJUDICATED THAT A SUSPECTED NON Q-WAVE MI OCCURRED ONE DAY POST INDEX PROCEDURE. LOCATION OF INFARCTION WAS REPORTED AS IN THE TERRITORY OF THE TARGET VESSEL. A MARKED RISE IN TROPONIN AND CK WAS NOTED. MI WAS CLASSED AS A RE-INFARCTION. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY FOLLOW UP, 6 MONTH FOLLOW UP, 1 YEAR FOLLOW UP, 1.5 YEAR FOLLOW UP, 2 YEAR FOLLOW UP AND 2.5 YEAR FOLLOW UP. (REF MFR # 9612164-2011-00610, 9612164-2011-00612 & 9612164-2011-00613).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR