BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3010198 · Received March 19, 2013

    Report

    Report Number
    9612164-2013-00311
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 4, 2013
    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 - (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) - 95% STENOSIS AND RESISTANCE AT LESION. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) - 95% STENOSIS AND RESISTANCE AT LESION. INHERENT RISK OF PROCEDURE - (FAILURE TO DELIVER STENT AND STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT IN A LESION WITH 95% STENOSIS IN THE RCA, THE STENT COULD NOT CROSS AND THE DEVICE WAS REMOVED. ANOTHER STENT WAS DEPLOYED. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 11TH AND 12TH DISTAL SEGMENTS WERE RAISED AND DEFORMED. 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
    114127 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006226814

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR