BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3940449 · Received July 17, 2014

    Report

    Report Number
    9612164-2014-00963
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    December 17, 2010
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). INHERENT RISK OF PROCEDURE ¿ (STENT FRACTURE). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE NOT RETURNED FOR EVALUATION. EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (STENT FRACTURE). (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE AN ENDEAVOR SPRINT DRUG-ELUTING STENT (2.75MM X 24MM) WAS IMPLANTED IN THE 3RD OBTUSE. STENT FRACTURE WAS REPORTED. NO TREATMENT WAS REPORTED AND PATIENT WAS DISCHARGED FROM HOSPITAL 2 DAYS LATER WITH NO ADVERSE EVENTS REPORTED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419339 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0001134680

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR