BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4222381 · Received November 4, 2014

    Report

    Report Number
    9612164-2014-01410
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 24, 2014
    Report Date
    October 28, 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) 22 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 30MM) TO A LESION IN THE LCX WITH 90% STENOSIS BUT THE DEVICE COULD NOT PASS. THE LESION HAD BEEN PRE-DILATED. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND THE STENT WAS OBSERVED TO BE DAMAGED. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE SECOND PROXIMAL STENT SEGMENT WAS 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
    708113 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007163951

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR