BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3933698 · Received July 15, 2014

    Report

    Report Number
    9612164-2014-00925
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    November 11, 2011
    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 IS DESCRIBED AS AN AE IN THE IFU). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (DISSECTION IS DESCRIBED AS AN AE IN THE IFU). (B)(4).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THE INDEX PROCEDURE. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413990 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005237322

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization ASA AND CLOPIDOGREL