BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1735968 · Received June 23, 2010

    Report

    Report Number
    2953200-2010-01195
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 20, 2016
    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): EVAL RESULTS: (ROOT CAUSE CANNOT BE DETERMINED BASED ON INFO AVAILABLE). (DEATH).

    Additional Manufacturer Narrative · 1

    PATIENT HAD A HISTORY OF HYPERLIPIDEMIA, DIABETES, HYPERTENSION, A PREVIOUS PCI AND PREVIOUS MYOCARDIAL INFARCTION. CURRENT CARDIAC STATUS IS OLD MYOCARDIAL INFARCTION. PATIENT'S FAMILY INFORMED HOSPITAL THAT PATIENT PASSED AWAY DUE TO AN ANEURYSM RUPTURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE DISTAL CIRCUMFLEX OF A PATIENT WITH NO ISSUE REPORTED. HOWEVER IT WAS REPORTED THAT, APPROX 5 MONTHS POST DEPLOYMENT OF THE RELEVANT STENT, THE PATIENT DIED. THE CAUSE OF DEATH IS UNK; HOWEVER, INVESTIGATOR REPORTED NO RELATIONSHIP BETWEEN THE EVENT AND THE RELEVANT STENT, DRUG OR PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death CLOPIDOGREL