BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4886317 · Received July 2, 2015

    Report

    Report Number
    9612164-2015-01175
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    July 4, 2014
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ROOT CAUSE UNDETERMINED; INHERENT RISK OF PROCEDURE (THROMBUS). EVALUATION CONCLUSIONS: ROOT CAUSE UNDETERMINED; KNOWN INHERENT RISK OF A PROCEDURE (THROMBUS). (B)(4). THE INFORMATION COULD NOT BE MATCHED WITH OTHER INFORMATION KNOWN TO MEDTRONIC. 1050-1738/<(>&<)> 2014 ELSEVIER INC. ALL RIGHTS RESERVED. HTTP://DX.DOI.ORG/10.1016/J.TCM.2014.07.004 "NOVEL DRUG-ELUTING STENTS FOR CORONARY REVASCULARIZATION.¿

    Description of Event or Problem · 1

    IT WAS NOTED DURING THE REVIEW LITERATURE ARTICLE TITLED: NOVEL DRUG-ELUTING STENTS FOR CORONARY REVASCULARIZATION THAT PATIENTS USING ENDEAVOR SPRINT DEVICES EXPERIENCED TARGET LESION REVASCULARIZATION, RESTENOSIS, DEATH, MI ,ST AND BLEEDING EVENTS, ALTHOUGH THESE EVENTS WERE FOUND TO BE LESS FREQUENT AS WITH EARLIER BMS AND DES DEVICES. IT WAS ALSO NOTED IN THE ARTICLE THAT PATIENTS TREATED WITH RESOLUTE INTEGRITY DEVICES EXPERIENCED TARGET LESION FAILURE, CARDIAC RELATED DEATH AND STENT THROMBOSIS EVENTS. THIS INFORMATION WAS POOLED OVER 5-YEAR RESULTS FROM 3616 PATIENTS IN THE ENDEAVOR CLINICAL TRIALS PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432887 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 ASA AND CLOPIDOGREL