BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4230877 · Received November 6, 2014

    Report

    Report Number
    9612164-2014-01433
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    June 9, 2013
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: (CVA/ STROKE). (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: THE INVESTIGATOR REPORTED THAT THE PATIENT DID NOT RECOVER FROM THE PREVIOUSLY REPORTED STROKE AND SUBCORTICAL BLEEDING WHICH OCCURRED APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST DIAGONAL DURING INDEX PROCEDURE. IT IS REPORTED THAT APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCED SUBCORTICAL BLEEDING AND STROKE . THE PATIENT UNDERWENT SURGERY APPROXIMATELY 1 MONTH LATER. INVESTIGATOR ASSESSED THE SUBCORTICAL BLEEDING AND STROKE EVENT TO BE NOT RELATED TO THE STUDY DEVICE, STUDY PROCEDURE OR ZOTAROLIMUS. PATIENT WAS BEING MONITORED. APPROXIMATELY 39.5 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. CAUSE OF DEATH IS REPORTED AS HYPERTONIC DEHYDRATION. PATIENT DEATH IS REPORTED TO BE NON-SUDDEN AND NON-CARDIAC.

    Description of Event or Problem · 1

    MULTI ORGAN FAILURE WAS CAUSED BY PREVIOUSLY REPORTED HYPERTONIC DEHYDRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713070 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R