BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1920007 · Received December 3, 2010

    Report

    Report Number
    2953200-2010-02382
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 30, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (CVA/STROKE); (HISTORY OF PREVIOUS STROKE). CONCLUSIONS: OTHER (PATIENT'S CONDITION PREDISPOSED EVENT).

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO STENTS; A 2.5MM DIAMETER X 12MM LENGTH AND A 2.5MM DIAMETER X 18MM LENGTH (REF MFR 2953200201002383) ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENTS TO THE PROXIMAL CIRCUMFLEX AND DISTAL CIRCUMFLEX. THIS FOLLOWED PRE-DILATATION OF THE LESION WITH A 2.25MM DIAMETER X 15MM LENGTH BALLOON. FOLLOWING POST-DILATATION, 0% STENOSIS REMAINED. THE PT WAS DISCHARGED FROM HOSPITAL AND APPROX THREE MONTHS POST-INDEX PROCEDURE, A STROKE WAS CONFIRMED. THE 12-MONTH FOLLOW-UP CONFIRMED NO ADVERSE EVENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT WAS DEPRESSED AND HAD LACK OF EXPRESSION. WHEN PATIENT CAME TO HOSPITAL CT CONFIRMED NO BRAIN BLEEDING. MRI CONFIRMED THROMBOTIC EMBOLISM AT MIDDLE CEREBRAL ARTERY REGION. THE PATIENT WAS TREATED WITH INTRAVENOUS DRIP. THE PATIENT WAS DISCHARGED 3 WEEKS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other ASPIRIN| CLOPIDOGREL