BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2820383 · Received November 6, 2012

    Report

    Report Number
    9612164-2012-01630
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 1, 2012
    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). EVALUATION, CONCLUSIONS: INHERENT RISK OF PROCEDURE (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE; ONE IN THE LAD AND THE OTHER IN THE CX. IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005237320

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization CLOPIDOGREL AND ASPIRIN