BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3231148 · Received July 17, 2013

    Report

    Report Number
    9612164-2013-00722
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION); PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (PATIENT LESION MORPHOLOGY, HEAVILY LESION WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS); DEFORMATION PROBLEM. CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (PATIENT LESION MORPHOLOGY, LESION WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS); KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.75 MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OSTIUM WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. IT WAS REPORTED THAT THE ENDEAVOR RESOLUTE STENT COULD NOT PASS THE LESION IN THE OSTIUM AND WHEN THE DEVICE WAS WITHDRAWN FROM THE PATIENT IT WAS NOTED THAT THE STENT WAS DEFORMED. NO PATIENT INJURY OR CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT. DEVICE EVALUATION: THE DISTAL TIP WAS FLARED. THE 1ST TEN PROXIMAL SEGMENTS WERE INTACT. THE 1ST TWO DISTAL SEGMENTS WERE PINCHED BUT INTACT. THE REMAINING SEGMENTS WERE DEFORMED AND SEVERELY STRETCHED. CINE IMAGE REVIEW OF THE PROCEDURAL IMAGES CONFIRMS THE TORTUOUS NATURE OF THE VESSEL. THERE ARE NO IMAGES CAPTURING THE ATTEMPTED DELIVERY AND SUBSEQUENT WITHDRAWAL OF THE ENDEAVOR RESOLUTE DEVICE. NUMEROUS PRE-DILATIONS ARE PERFORMED PRIOR TO THE SUCCESSFUL DEPLOYMENT OF TWO STENT. 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
    331421 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006634108

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR