BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7649591 · Received June 29, 2018

    Report

    Report Number
    9612164-2018-01580
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    March 29, 2017
    Report Date
    June 29, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: A CASE OF DOUBLE STENT IMPLANTATION FOR LEFT MAIN CORONARY ARTERY OCCLUSION IN TRANSCATHETER AORTIC VALVE IMPLANTATION USING SAPIEN XT DEVICE AUTHORS: MASAKI ITO; NORIO TADA; TATSUSHI OOTOMO JOURNAL: CARDIOVASCULAR INTERVENTION AND THERAPEUTICS ISSUE: 32 REF: DOI 10.1007/S12928-017-0467-8. DATE OF PUBLICATION A TOMOGRAPHY IMAGE OF THE AORTIC ROOT SHOWED AORTIC ANNULUS AREA WAS CALCULATED TO BE 556 MM2, DISTANCE BETWEEN THE AORTIC ANNULUS AND LMCA WAS 12.6 MM. AND MINIMUM VALSALVA DIAMETER WAS 35.2 MM. D SEVERE CALCULUS WAS OBSERVED ON THE TIP OF THE LEFT CORONARY LEAFLET. IMAGES IN SHOW THE TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE DURING WHICH BALLOON AORTIC VALVULOPLASTY USING A 25-MM BALLOON REVEALING LEFT MAIN CORONARY ARTERY OCCLUSION. PROTECTION WAS ACHIEVED WITH A 6-FR JUDKINS LEFT 3.5 GUIDING CATHETER AND TWO 0.014- IN. GUIDEWIRES. RUNTHROUGH NS FLOPPY AND NEO¿S SOFT GUIDEWIRES WERE ADVANCED INTO THE LEFT ANTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX ARTERY, RESPECTIVELY. AORTOGRAPHY IMAGE JUST AFTER 29-MM SAPIEN XT IMPLANTATION REVEALED A LEFT MAIN CORONARY ARTERY OCCLUSION IMAGES OF THE POST-DILATATION PROCEDURE, AFTER RESOLUTE INTEGRITY STENTING SHOW THE WEDGE AT THE STENTED LESION IN THE PROTRUDING AND OSTIUM AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALING THAT THE STENT WAS COMPRESSED AT THE PROTRUDING SITE BY SAPIEN XT. IMAGE OF THE NOBORI STENT THAT WAS PLACED INSIDE THE 4.0/26-MM RESOLUTE INTEGRITY STENT IS ALSO PROVIDED ASWELL AS FINAL ANGIOGRAPHY REVEALING THROMBOLYSIS IN MYOCARDIAL INFARCTION GRADE 3 FLOW. AFTER SECOND STENT IMPLANTATION, THE STENT WAS CIRCULARLY EXPANDED. TWO LAYERS OF STENT STRUTS WERE CONFIRMED AND SAPIEN XT WAS ALSO CONFIRMED ONCE MORE. IMAGES AT 6 MONTHS POST PROCEDURE SHOW THE IMPLANTED STENT PROTRUDING INTO THE AORTA AND STENT PATENCY. SEVERE CALCULUS WAS REMOVED FROM THE LEFT MAIN CORONARY ARTERY OSTIUM BY THE STENT. A SECOND IMAGE SHOWS THE IMPLANTED STENT OVERCOMING THE EXTERNAL COMPRESSION BY THE SAPIEN XT IN THE RELATIVELY SMALL SINUS OF VALSALVA. AN IMAGE SHOWED THE DEPTH OF VALVE IMPLANTATION FROM THE NATIVE ANNULUS WAS 5.3 MM AT LEFT CORONARY CUSP. THE IMAGES IN THE JOURNAL ARTICLE CONFIRMED THE STENT WAS COMPRESSED. DESPITE 4-MM STENT IMPLANTATION AND POST-DILATATION WITH A 5-MM BALLOON, THE STENT WAS COMPRESSED IN THE PROTRUDING PART BY SAPIEN XT. THE HEIGHT OF 29-MM SAPIEN XT VALVE IS RELATIVELY LONG COMPARED TO THE SIZE OF THE LEFT SINUS OF VALSALVA, AND THE STENT WAS DISTORTED BY THE SAPIEN XT FRAME STRUTS. IT WAS REPORTED THAT IT WAS ATTEMPTED TO IMPLANT THE SAPIEN XT VALVE DEEPER THAN THE USUAL CASE; HOWEVER, THE VALVE WAS IMPLANTED HIGHER THAN EXPECTED. IF THE PROSTHESIS HAD BEEN IMPLANTED DEEPER, CORONARY OCCLUSION AND STENT DISTORTION MAY HAVE BEEN AVOIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AFTER NON-MEDTRONIC VALVE IMPLANTATION, AORTOGRAPHY DEMONSTRATED THROMBOLYSIS IN MYOCARDIAL INACTION (TIMI) GRADE 1 FLOW IN THE LEFT CORONARY ARTERY. PCI WAS PERFORMED WITH THE IMPLANTATION OF RESOLUTE INTEGRITY IN THE LMCA WITH PROTRUSION INTO THE AORTA OVER THE SAPIEN XT FRAME STRUTS. THE LESION WAS THEN POST DILATED WITH A NC PTA BALLOON. ANGIOGRAPHY POST IMPLANT REVEALED A WEDGE AT THE STENTED LESION AND IVUS REVEALED THAT THE STENT WAS COMPRESSED IN THE PROTRUDING PART OF THE SAPIEN XT FRAME STRUTS. A SECOND NON-MEDTRONIC STENT WAS IMPLANTED IN THE COMPRESSED PART WITH THE PROXIMAL EDGE PROTRUDING FROM THE FIRST STENT, FOLLOWED BY POST-DILATATION WITH A NC PTA BALLOON. ANGIOGRAM REVEALED A GRADE 3 TIMI FLOW WITH NO RESIDUAL STENOSIS. IVUS CONFIRMED EXCELLENT EXPANSION OF THE STENT. TEE CONFIRMED RESTORATION OF THE LEFT VENTRICULAR WALL MOTION. PATIENT WAS HEMODYNAMICALLY STABLE AND PROCEDURE SUCCESSFULLY FINISHED. THE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK, AND A PERMANENT PACEMAKER WAS IMPLANTED 3 DAYS AFTER THE PROCEDURE. THE PATIENT RECOVERED AND WAS DISCHARGED 14 DAYS AFTER THE PROCEDURE. AT HER 6-MONTH FOLLOW-UP, THE PATIENT WAS IN GOOD GENERAL CONDITION WITHOUT ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493054 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention