BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3024316 · Received March 27, 2013

    Report

    Report Number
    9612164-2013-00342
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 5, 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 - (DEFORMATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) - 95% STENOSIS AND SEVERE CALCIFICATION. (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) - 95% STENOSIS AND SEVERE CALCIFICATION. INHERENT RISK OF PROCEDURE - (DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A LESION IN THE RCA WITH 95% STENOSIS AND SEVERE CALCIFICATION BUT THE STENT COULD NOT PASS THE LESION. THE PHYSICIAN REMOVED THE DEVICE. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 8TH AND 9TH PROXIMAL SEGMENTS WERE PINCHED. 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
    125913 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006161138

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR