BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2895933 · Received January 4, 2013

    Report

    Report Number
    9612164-2013-00017
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    October 12, 2012
    Report Date
    January 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (CVA/STROKE). CONCLUSIONS: INHERENT RISK OF PROCEDURE (CVA/STROKE). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 17 DAYS POST INDEX PROCEDURE, DURING A STAGED PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE LAD. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5281 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001139863

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization ASPIRIN