BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3962570 · Received July 29, 2014

    Report

    Report Number
    9612164-2014-01004
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿90% STENOSIS. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 90% STENOSIS. INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT (2.50MM X 18MM) TO A LESION IN THE LAD WITH 90% STENOSIS BUT THE DEVICE COULD NOT CROSS THE 1ST DIAGONAL BRANCH. THE PATIENT IS GOOD. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THERE WAS NUMEROUS SMALL BENDS ALONG THE HYPOTUBE. THE DISTAL TIP WAS FLARED INDICATING IT MAY HAVE BEEN STUBBED ON ADVANCEMENT TOWARDS THE TARGET LESION. MULTIPLE STRUTS FROM THE 4TH AND 5TH PROXIMAL STENT SEGMENTS WERE SLIGHTLY MISALIGNED AND RAISED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440711 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006797647

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR