BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3994182 · Received August 8, 2014

    Report

    Report Number
    9612164-2014-01056
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 24, 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

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ 97% STENOSIS. DEFORMATION PROBLEM. CONCLUSION RESULTS: INHERENT RISK OF PROCEDURE ¿ (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 97% STENOSIS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PHYSICIAN WAS USING AN ENDEAVOR RESOLUTE DRUG ELUTING STENT TO TREAT A LESION IN THE LAD. THE LESION WAS REPORTED TO BE 97% STENOSED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE HYPOTUBE WAS KINKED DISTAL TO THE STRAIN RELIEF. THE 6TH AND THE 14TH STENT 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
    467993 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007024156

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR