BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 21273798 · Received January 30, 2025

    Report

    Report Number
    2025587-2025-00852
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 17, 2023
    Report Date
    January 30, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. IMAGE REVIEW: THERE IS AN IMAGE TAKEN FROM THE FLOURSCOPIC LOAD INSPECTION. ALTHOUGH THERE IS EVIDENCE OF INFLOW CROWN OVERLAP, THE OVERLAP DOES NOT APPEAR TO EXTEND PAST THE 4TH NODE. AS SUCH THIS INDICATES A CORRECT LOAD ACCORDING TO INSTRUCTIONS FOR USE (IFU) AND BEST PRACTICES. THERE IS NO OTHER EVIDENCE THAT INDICATES A MISLOAD. ANOTHER IMAGE SHOWS A DEPLOYMENT ASSESSMENT IN RAO AND LAO VIEWS. IN THE RAO VIEW, SEVERE FRAME UNDER EXPANSION FROM THE NON-CORONARY ANNULS AND INFOLDING AT THE LEFT-CORONARY ANNULUS ARE VISIBLE. THE LAO VIEW SHOWS SIGNS OF INFOLDING MARGINALLY HIDDEN BY THE PIGTAIL CATHETER. ACCORDING TO THE REPORT THIS DEPLOYMENT ATTEMPT WAS RECAPTURED, AND NEW VALVE AND DELIVERY SYSTEM WERE USED FOR A SECOND IMPLANT ATTEMPT. IMAGES SHOW THE DEPLOYMENT OF THE SECOND VALVE AT 80% IN RAO AND THE FULL DEPLOYMENT IN LAO. IN THE FIRST IMAGE THERE IS EVIDENCE OF FRAME INFOLDING. IT IS WORTH NOTING THAT WITH ANY EVIDENCE OF FRAME INFOLDING THE VALVE SHOULD BE RECAPTURED AND A NEW VALVE USED FOR ANOTHER DEPLOYMENT ATTEMPT. IN THIS CASE THE VALVE WAS RELEASED AGAINST BEST PRACTICES. IN THE FULL RELEASE IMAGE, THE FRAME APPEARS SEVERELY CONSTRICTED. THERE ARE IMAGES THAT SHOW A POST BALLOON AND FINAL ANGIOGRAM OF SECOND DEPLOYMENT ATTEMPT. THE VALVE APPEARS TO EXPAND WITHOUT ANY APPARENT CONSTRICTIONS. FINAL ANGIOGRAM SHOWS THE VALVE TO BE SUITABLY EXPANDED IN THE LAO VIEW WITH EVIDENCE OF PARAVALVULAR LEAK (PVL) AS INDICATED. THERE IS NO EVIDENCE IN THE SUPPLIED MATERIAL THAT INDICATES THE REASON FOR DIFFICULTY DURING LOADING. NO CINES OF ANY OF THE RECAPTURE ATTEMPTS WERE PROVIDED. NO ADVERSE PATIENT EVENTS REPORTED. 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 ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS DIFFICULTY LOADING THE VALVE, HOWEVER A MISLOAD WAS NOT REPORTED. IT WAS REPORTED THAT THE VALVE PULLED IN THE CAPSULE INSTEAD OF LOADING WHILE THE CAPSULE MOVED FORWARD. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20MM NON-MEDTRONIC BALLOON. UPON INITIAL DEPLOYMENT, THE VALVE DID NOT EXPAND AS EXPECTED. A POSSIBLE INFOLD INVOLVING NODES 1,2, 3 WAS OBSERVED. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE WITHDRAWN FROM THE PATIENT. ACCORDING TO THE PHYSICIAN, CALCIUM IN ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CONTRIBUTED TO THE UNDER-EXPANSION AND INFOLD. A NEW VALVE WAS SUCCESSFULLY LOADED ON A NEW DCS WITH NO ISSUE. UPON DEPLOYMENT, THE SECOND VALVE APPEARED UNDER-EXPANDED. THE VALVE WAS FULLY RELEASED AND POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A GOOD RESULT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589352 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male