BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1891176 · Received October 29, 2010

    Report

    Report Number
    2953200-2010-02092
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    February 3, 2010
    Report Date
    September 29, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DEATH, ROOT CAUSE OF EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE PROXIMAL CIRCUMFLEX, FOLLOWING PRE-DILATATION OF THE LESION WITH A 2.5MM DIAMETER X 15MM LENGTH BALLOON. NO ISSUE WAS REPORTED. DURING THE PROCEDURE, TWO OTHER STENTS WERE DEPLOYED, A 2.5MM DIAMETER X 24MM LENGTH AND A 2.75MM DIAMETER X 12MM LENGTH RAPID EXCHANGE (RX) TO THE PROXIMAL LEFT ANTERIOR DESCENDING AND MID LEFT ANTERIOR DESCENDING. (MFR REPORT NUMBERS 2953200-2010-00809 AND 2953200-2010-00810). IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST-INDEX PROCEDURE, THE PT PASSED AWAY FROM HEART FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death CLOPIDOGREL| ASPIRIN