BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1671610 · Received April 28, 2010

    Report

    Report Number
    2953200-2010-00734
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    November 21, 2009
    Report Date
    April 2, 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: STENT THROMBOSIS, DEATH.

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 24MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN A PT WITH NO ISSUE REPORTED. THE TARGET LESION, LOCATED IN THE LCX # 13-14 WAS DESCRIBED AS NON TORTUOUS WITH NO CALCIFICATION AND 99% STENOSIS AND WAS PREDILATED. HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS POST IMPLANT, THE PT PRESENTED IN A STATE OF CARDIOPULMONARY ARREST AND DIED ON THE SAME DAY. COMMUNICATION FROM THE FIELD REPORTED THAT WHETHER THE PT PRESENTED STENT THROMBOSIS OR NOT IS UNK; EVEN WHETHER THE CAUSE OF DEATH WAS ASSOCIATED WITH HEART OR NOT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001043297

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CLOPIDOGREL| ASPIRIN| HEPARIN| CILOSTAZOL