BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3091382 · Received May 3, 2013

    Report

    Report Number
    9612164-2013-00504
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (DISLODGEMENT); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) - 80% STENOSIS AND SEVERE CALCIFICATION. FAILURE TO FOLLOW INSTRUCTIONS - (FORCE WAS USED IN AN ATTEMPT TO DELIVER THE STENT ACROSS THE LESION.) CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) - 80% STENOSIS AND SEVERE CALCIFICATION. INHERENT RISK OF PROCEDURE - (DISLODGEMENT); USER ERROR CONTRIBUTED TO EVENT - (FORCE WAS USED IN AN ATTEMPT TO DELIVER THE STENT ACROSS THE LESION.) (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO DELIVER ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT TO A SEVERELY CALCIFIED LESION IN THE LAD WITH 90% STENOSIS BUT THE DEVICE COULD NOT PASS THROUGH THE LESION. STENT DISLODGED AND HAD TO BE RETRIEVED FROM THE PATIENT. EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED AND DAMAGED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. THE STENT WAS NOT RETURNED WITH THE DEVICE. CRIMP IMPRESSIONS WERE EVIDENT ALONG THE BALLOON. THE PROXIMAL PILLOW BALLOON FOLDS WERE PARTIALLY OPENED AND DISTURBED. IMAGE REVIEW: THE PROCEDURAL IMAGES PROVIDED BY THE ACCOUNT CONFIRM THE TORTUOUS AND CALCIFIED NATURE OF THE LAD VESSEL AND SIDE BRANCH. THE IMAGES CAPTURE NUMEROUS PRE-DILATIONS OF THE LAD AND THE SIDE BRANCH PRIOR TO SUCCESSFUL DEPLOYMENT OF A STENT IN THE PROXIMAL TO MID LAD. THERE ARE NO IMAGES CAPTURING THE ATTEMPTED DELIVERY OR WITHDRAWAL OF THE RESOLUTE STENT. A STENT IS SUBSEQUENTLY DEPLOYED IN THE LEFT MAIN OVERLAPPING WITH THE STENT IN THE PROXIMAL/MID LAD. 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
    194439 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006179308

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention