BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2914826 · Received January 15, 2013

    Report

    Report Number
    9612164-2013-00068
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    January 11, 2013
    Report Date
    June 6, 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

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT).

    Description of Event or Problem · 1

    DATE OF DEATH RECEIVED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING-STENT IMPLANTED IN THE RCA. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT (CVA). PATIENT WAS TREATED WITH MEDICATION AND THROMBOLYTIC THERAPY.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED STROKE HAS BEEN ASSESSED AS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT DIED APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH STROKE. INVESTIGATOR DID NOT INDICATE WHETHER THE REPORTED DEATH WAS RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22760 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death| H CLOPIDOGREL AND ASPIRIN.