BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4222481 · Received November 4, 2014

    Report

    Report Number
    9612164-2014-01414
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 2, 2014
    Report Date
    October 14, 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 95% STENOSIS). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY 95% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE AN ENDEAVOR RESOLUTE DRUG ELUTING STENT IN A TARGET LESION LOCATED IN THE RCA AND EXHIBITING 95% STENOSIS. THE LESION WAS PRE-DILATED BUT THE DEVICE COULD NOT PASS THE LESION. DEVICE WAS PREPPED WITH NO ISSUES NOTED PRIOR TO USE. NO RESISTANCE WAS NOTED AT THE LESION. THE PHYSICIAN USED A NEW DEVICE TO COMPLETE THE SURGERY. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE STENT WAS POSITIONED ON THE BALLOON BETWEEN THE INNER SHAFT MARKERS AS PER SPECIFICATION REQUIREMENTS, HOWEVER THE 7TH, 8TH, 9TH AND 10TH PROXIMAL SEGMENTS ARE 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
    705495 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006814093

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR