BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3003351 · Received March 14, 2013

    Report

    Report Number
    9612164-2013-00281
    Event Type
    Death
    Date Received
    March 14, 2013
    Date of Event
    February 22, 2010
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT DRUG-ELUTING STENT WAS IMPLANTED AT THE MID LAD. IT IS REPORTED THAT A DISSECTION OCCURRED PRIOR TO STENT IMPLANTATION. ONE ENDEAVOR SPRINT DRUG-ELUTING STENT WAS IMPLANTED AT THE 1ST OBTUSE MARGINAL. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. INVESTIGATOR DID NOT INDICATE WHETHER THE REPORTED STROKE WAS RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE YEAR AFTER THE INDEX PROCEDURE DUE TO UTERUS CANCER AND NODULES WHICH HAD SPREAD TO THE LUNGS. THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107744 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death CLOPIDOGREL AND ASPIRIN.