BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 21255403 · Received January 28, 2025

    Report

    Report Number
    2025587-2025-00688
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    May 31, 2022
    Report Date
    January 28, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RECEIVED VIA FEDEX IN OUTER PACKAGING OF F002107 (REPLACEMENT VALVE) IN ORIGINAL JAR SUBMERGED IN CLEAR SOLUTION. ALL LEAFLETS WERE FLEXIBLE AND APPEARED INTACT. COAPTATION: AS RECEIVED, ALL LEAFLETS WERE IN THE CLOSED POSITION WITH GAPS BETWEEN L1/L2 AND L1/L3. COMMISSURES: ALL COMMISSURES WERE INTACT. THE VALVE WAS PLACED IN A COLD SALINE BATH TO PERFORM LOADING SIMULATION PER APPROPRIATE INSTRUCTIONS FOR USE (IFU). UPON LOADING, BOTH FRAME PADDLES APPEARED SEATED WITHIN THE PADDLE ATTACHMENT POCKETS. THE CAPSULE WAS ADVANCED COVERING THE FRAME PADDLES AND OUTFLOW CROWN STRUTS. THE CAPSULE WAS ADVANCED UNTIL THE CAPSULE GUIDE TUBE COVERED THE COMMISSURE PAD OF THE VALVE. THE INFLOW CONE WAS ADVANCED TO CRIMP THE INFLOW PORTION OF THE VALVE. THE CAPSULE WAS FULLY ADVANCED OVER THE VALVE; NO VISUAL OR TACTILE ANOMALIES WERE NOTED. THE VALVE WAS THEN DEPLOYED IN A WARM SALINE BATH BY ROTATING THE DEPLOYMENT KNOB EXPOSING THE VALVE. THE VALVE CONTINUED TO BE DEPLOYED UP TO THE POINT OF NO RECAPTURE; NO ANOMALIES WERE NOTED. TO SIMULATE THE REPORTED EVENT, THE VALVE WAS RECAPTURED; VALVE RETRACTED WITHOUT ISSUES OR ANOMALIES. THE VALVE WAS SUBSEQUENTLY DEPLOYED AND APPEARED TO EXHIBIT A COMPLETE DILATION; NO ANOMALIES WERE NOTED. TO ADDRESS THE ALLEGATION OF LEAFLET FUNCTIONALITY. THE VALVE WAS SUBJECTED TO STEADY FLOW TESTING FOR BOTH FORWARD FLOW AND BACK PR ESSURE. THE VALVE SUCCESSFULLY COMPLETED BOTH TESTS. THE TEST VALVE DEMONSTRATED AN INCREASE IN PRESSURE DROP WITH INCREASING FLOW RATE WHICH IS EXPECTED AND CONSISTENT WITH THE PRESSURE DROP BEHAVIOR OF THE STANDARD FORWARD FLOW NOZZLE, AND THE TEST VALVE DEMONSTRATED INCREASING LEAKAGE WITH INCREASING PRESSURE, WHICH IS EXPECTED AND CONSISTENT WITH LEAKAGE BEHAVIOR OBSERVED ON THE BACK FLOW NOZZLE. IN ADDITION, VISUAL OBSERVATION OF THE LEAFLETS DETECTED NO ABNORMALITIES. THUS, THE RESULTS OF THIS TESTING DEMONSTRATE PROPER VALVE FUNCTIONING. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS LOADED ONCE WITH NO MISLOAD. AFTER PREDILATATION WITH AN 18 MILLIMETER (MM) BALLOON VIA MANUAL PRESSURE, THE VALVE APPEARED UNDER-EXPANDED WITH NO HEMODYNAMICS. AFTER THE SECOND RECAPTURE AND INFOLDING WAS OBSERVED TO THE FIFTH NODE. THE VALVE WAS RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THREE RECAPTURES HAD BEEN PERFORMED AND THE VALVE MOVED TOWARDS THE VENTRICLE DURING DEPLOYMENT. THE TARGET IMPLANT DEPTH OF 15 MM WAS REPORTED AND CUSPAL OVERLAP TECHNIQUE WAS USED. AN ATTEMPT TO ALIGN THE COMMISSURES WAS MADE. UPON INSPECTION OF THE VALVE, IT WAS UNCLEAR IF ONE OF THE LEAFLETS WAS FUNCTIONAL. A NEW VALVE WAS USED. IT WAS REPORTED THAT THE BEND OF THE AORTIC ARCH AND CALCIFICATION MAY HAVE CONTRIBUTED TO THE INFOLDING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548795 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown