BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT CORONARY STENT SYSTEM

    MDR report key: 2230594 · Received August 11, 2011

    Report

    Report Number
    9612164-2011-00921
    Event Type
    Death
    Date Received
    August 11, 2011
    Date of Event
    June 3, 2012
    Report Date
    November 29, 2016
    Manufacturer
    MEDTRONIC IRELAND
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (DISSECTION, CVA/STROKE), (ROOT CAUSE UNK).

    Additional Manufacturer Narrative · 1

    PATIENT HISTORY INCLUDES PRIOR PCI. INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA.THE PREVIOUSLY REPORTED DEATH WAS SUDDEN ,NON-CARDIAC. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT RX CORONARY STENT INTO A PT. HOWEVER IT WAS REPORTED THAT A DISSECTION HAD OCCURRED, FOLLOWING POST-DILATATION. INTRAVASCULAR ULTRASOUND CHECK CONFIRMED THE COMPLETE APPOSITION OF THE STENT TO THE VESSEL WALL. PT WAS DISCHARGED FROM HOSP ON THE FOLLOWING DAY. APPROX 9 MONTHS POST INDEX PROCEDURE PT WAS HOSPITALIZED SUFFERING AN ISCHEMIC STROKE. THE INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE STUDY DEVICE/PROCEDURE DRUG. PT WAS TREATED WITH ORAL DRUG AND REHAB.

    Description of Event or Problem · 1

    PATIENT HAD LEFT HEMIPLEGIA AND UNABLE TO ARTICULATE PROPERLY. PATIENT WAS TREATED WITH DRUG. PHYSICIAN DIAGNOSIS WITH MRI WAS THAT PATIENT HAD ATHEROTHROMBOTIC BRAIN INFARCTION COMING FROM THE RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS HOSPITALIZED FOR REHABILITATION.

    Description of Event or Problem · 1

    APPROXIMATELY (B)(6) MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED AFTER BEEN RUSHED TO HOSPITAL. IT WAS CONSIDERED THAT THE ROOT CAUSE WAS PNEUMONIA AS IT WAS NOTED THAT THE PATIENT HAD A FEVER AND DECREASING OXYGEN SATURATION WHILE BEEN TRANSFERRED TO THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| S RADICUT AND ARGATROBAN