BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4870571 · Received June 26, 2015

    Report

    Report Number
    9612164-2015-01102
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    March 10, 2015
    Report Date
    May 29, 2015
    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

    PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED LESION WITH 90% STENOSIS LEVEL IN A TORTUOUS VESSEL). INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEFORMATION PROBLEM (STENT). FAILURE TO FOLLOW INSTRUCTIONS (IFU STATES NOT TO USE EXCESSIVE FORCE DURING THE DEVICE ADVANCEMENT). KNOWN INHERENT RISK OF A PROCEDURE (STENT DEFORMATION). DEVICE FAILURE RELATED TO PATIENT CONDITION (CALCIFIED LESION WITH 90% STENOSIS LEVEL IN A TORTUOUS VESSEL). (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PHYSICIAN INTENDED TO USE AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT TO TREAT CALCIFIED LESION WITH 90% STENOSIS LEVEL IN A TORTUOUS PROX-LAD. THE LESION WAS PRE DILATED. IT IS REPORTED THAT STENT DAMAGE WAS NOTED UPON UNSUCCESSFUL DELIVERY; UPON DEVICE INSPECTION POST ITS REMOVAL. THE DEVICE WAS REMOVED FROM THE PACKAGING PER THE INSTRUCTIONS FOR USE, INSPECTED PRIOR TO USE AND PREPPED WITH NO ISSUES IDENTIFIED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED DUE TO THE LESION CALCIFICATION. THE PHYSICIAN BELIEVES THAT THE EVENT WAS DUE TO USE OF THE DEVICE IN DIFFICULT LESION MORPHOLOGY/ANATOMY. THE PROCEDURE WAS COMPLETED WITH 2.75MM X 24MM DEVICE. NO PATIENT INJURY REPORTED. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED ENDEAVOR RESOLUTE DEVICE SHOWED EVIDENCE OF STENT DEFORMATION. THE 11TH, 12TH, 13TH AND 17TH DISTAL STENT SEGMENTS WERE DEFORMED WITH NUMEROUS RAISED STRUTS. THE DISTAL TIP OF THE DEVICE WAS SLIGHTLY FLARED. CINE IMAGE REVIEW: CARDIO ANGIOGRAM (CAG) SHOWS EVIDENCE OF SEVERE CALCIFICATION AND STENOSIS PRESENT IN BOTH VESSELS. THE IMAGES SHOWS A PREVIOUSLY DEPLOYED STENT PRESENT IN ONE OF THE VESSELS. A STENT IS BEING DEPLOYED IN THE LCX VESSEL, THE IMAGES SHOW THAT THE NEWLY DEPLOYED STENT APPEARS TO TAKE THE SHAPE OF THE VESSEL, INDICATING THAT THE CALCIFICATION PRESENT MAYBE VERY RESISTANT TO STENTING. THE STENT IS POST DILATED AND THE BALLOON DOES NOT APPEAR TO BE EVENLY EXPANDED INDICATING THAT THE CALCIFICATION PRESENT IS RESISTANT TO BALLOONING. THE CAG SHOWS EVIDENCE OF PRE-DILATION IN THE LAD, THE BALLOON DOES NOT APPEAR TO BE EXPANDING EVENLY MOST LIKELY DUE TO THE PRESENCE OF SEVERE CALCIFICATION. THE CAG IMAGES SHOWS THE BIFURCATION OF THE TWO VESSELS BEING PRE-DILATED. POST DILATION WITH THE BALLOON SHOWS THE VESSEL STILL HAS A HIGH LEVEL OF CALCIFICATION AND STENOSIS PRESENT. THE CAG IMAGE SHOWS THE POSITIONING OF THE STENT IN THE VESSEL. THE CAG IMAGE SHOWS THE STENT NOT DEPLOYING EVENLY IN THE VESSEL. THERE APPEARS TO BE RESISTANT CALCIFICATION IN THE VESSEL. STENT DEFORMATION CANNOT BE CONFIRMED FROM THE IMAGES. THE CAG IMAGE SHOWS THE USE OF A PROCEDURE KNOWN AS KISSING BALLOON TECHNIQUE BEING USED IN THE VESSELS. THIS TECHNIQUE WAS MOST LIKELY USED TO OPEN UP THE AREA AT THE BIFURCATE OF THE TWO VESSELS. THE FINAL IMAGE SHOWS THE VESSELS TO SLIGHTLY MORE OPENED WITH LESS CALCIFICATION. ALTHOUGH THE VESSEL STILL HAS EVIDENCE OF CALCIFICATION PRESENT. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE (RESOLUTE INTEGRITY). THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENTS IN 803 WHICH IS LIMITED TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416097 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007322689

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR