BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1063499 · Received June 20, 2008

    Report

    Report Number
    2953200-2008-00450
    Event Type
    Death
    Date Received
    June 20, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: OTHER - (LACK OF INFO, NO FILMS RECEIVED. OTHER - SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 14 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT SYS WAS IMPLANTED INTO A PT FOR TREATMENT OF LESION IN THE LEFT MAIN TO THE CIRCUMFLEX ARTERY. THE VESSEL MORPHOLOGY WAS REPORTED AS EXTENSIVELY DISEASED AND 100% OCCLUDED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED ANOTHER MFR'S STENT FIRST; HOWEVER, IT WAS UNABLE TO CROSS THE LESION AND WAS REMOVED. THE LESION WAS PRE-DILATED A SECOND TIME. THE ENDEAVOR DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT A WEEK LATER, THE PT PRESENTED IN CARDIOGENIC SHOCK. WHEN THEY TOOK PICTURES, IT WAS NOTED THAT THE ENTIRE LEFT MAIN WAS THROMBOSED; WITH FLOW GOING INTO THE CIRCUMFLEX. THE LESION WAS PRE-DILATED; THREE STENTS WERE PLACED. THE PT WAS TAKEN BACK TO THEIR ROOM; HOWEVER, A COUPLE HRS LATER, THE VESSEL HAD COMPLETELY SHUT DOWN. THE PT WAS TRANSFERRED TO ANOTHER HOSP WHERE IT WAS REPORTED THAT HAD EXPIRED AT AN UNK DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000593690

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R GIVE 75MG OF PLAVIX AND 325MG OF ASPIRIN DURING| PT STARTED ON INTEGRILIN DRIP| 5 DAYS OF HOSP STAY.