BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 1031179 · Received April 18, 2008

    Report

    Report Number
    2953200-2008-00233
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 12, 2007
    Report Date
    February 29, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH STABLE ANGINA. MEDICATIONS PRESCRIBED AT THE DAY OF THE PROCEDURE AS FOLLOWS: ASPIRIN = 100MG; CLOPIDOGREL = 75MG. THE LESION TREATED WAS LOCATED IN THE MID RCA. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (2.75 X 24 MM STENT) 18 MONTHS AGO. FIVE MONTHS POST IMPLANT, THE INVESTIGATOR REPORTED A NON-DETERMINABLE NON-Q-WAVE MI. ON THE SAME DAY A CABG OF THE MID LAD AND LCX WAS PERFORMED. ON REVIEW, THIS WAS DEEMED TARGET LESION CABG AS THE RCA WAS ALSO GRAFTED. THE INDICATION WAS UNSTABLE ANGINA. THE INVESTIGATOR STATED MI EVENT AND THE ENDEAVOR DEVICE WERE UNRELATED. AT 6 MONTHS FOLLOW UP 2007, THE PATIENT HAD UNSTABLE ANGINA. AT 12 MONTH VISIT THE PATIENT HAD NO ANGINAL COMPLAINTS. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention CLOPIDOGREL 75MG STARTED GREATER THAN 3 DAYS OF| THE PROCEDURE.| PROCEDURE.| ASPIRIN 100MG STARTED GREATER THAN 3 DAYS OF THE