BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1920047 · Received December 3, 2010

    Report

    Report Number
    2953200-2010-02389
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    December 12, 2008
    Report Date
    November 8, 2010
    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).

    Description of Event or Problem · 1

    ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED TO THE MID LAD (MFR# 2953200200900870), AS TREATMENT OF TARGET LESION. ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED TO THE MID LAD (MFR# 2953200201002388) (OVERLAPPING), AS TREATMENT OF COMPLICATION/DISSECTION/BAILOUT. ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED TO THE DISTAL LAD. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY AND SIX MONTH FOLLOW UP. A PTCA REVASCULARIZATION OF THE PROXIMAL LAD WAS CARRIED OUT APPROX 4 MONTHS FOLLOWING INDEX PROCEDURE. ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. A SUSPECTED MI OCCURRED DURING THE INDEX OR RE-PCI PROCEDURE, CATEGORIZED AS A NON Q-WAVE MI IN THE TERRITORY OF THE TARGET VESSEL. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000746689

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization