BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3931155 · Received July 14, 2014

    Report

    Report Number
    9612164-2014-00902
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    December 7, 2010
    Report Date
    June 18, 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 ¿ (DISSECTION). CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED INTO THE RCA. TWO FURTHER ENDEAVOR SPRINT STENTS WERE ALSO IMPLANTED IN THE RCA. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THE INDEX PROCEDURE DURING THE IMPLANTATION OF THE ADDITIONAL TWO STENTS. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410768 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000907644

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization