BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 6184778 · Received December 19, 2016

    Report

    Report Number
    9612164-2016-01320
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED AND DIED AFTER THE PROCEDURE. PHYSICIAN COMMENTED THE EVENT WAS NOT RELATED TO THE MEDTRONIC DEVICE. THE HOSPITAL WOULD NOT PROVIDE MORE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838137 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND A007852814

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death