BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX PLUS VALVE

    MDR report key: 21594138 · Received March 13, 2025

    Report

    Report Number
    2025587-2025-01866
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    March 6, 2025
    Report Date
    June 5, 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

    CONTINUATION OF D10: PRODUCT ID: D-EVOLUTFX-34 (LOT: 0012619669); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE. PRODUCT ID: D-EVOLUTFX-34 (LOT: 0012569188); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE DEVICE. PRODUCT ID: EVFXPLUS-34 (K028641); PRODUCT TYPE: 0195-HEART VALVES; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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.

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: TWO STATIC IMAGES WERE PROVIDED FOR REVIEW. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. FLUOROSCOPY VALVE LOAD INSPECTION WAS NOT PROVIDED FOR REVIEW THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), ADEQUATE PREDILATATION CAN HELP REDUCE THE NEED FOR POST DILATATION AND MAY MITIGATE THE OCCURRENCE OF INFOLDING. PREDILATATION IS SPECIFICALLY RECOMMENDED PRIOR TO IMPLANTATION IN THE FOLLOWING SITUATIONS: MODERATE-SEVERE CALCIFICATION; BICUSPID ANATOMY; SIZE 34 MM VALVE. IN THIS CASE, IT IS NOT KNOWN IF A PRE BALLOON AORTIC VALVULOPLASTY WAS PERFORMED PRIOR TO THE VALVE IMPLANT. IT WAS REPORTED THAT TWO RECAPTURES WERE PERFORMED AND DURING THE THIRD IMPLANTATION ATTEMPT, AN INFOLD OCCURRED. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. ACCORDING TO MEDTRONIC BEST PRACTICES, IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND DISCARDED. NEW STERILE COMPONENTS MUST BE USED. SINCE FLUOROSCOPY VALVE LOAD INSPECTION WAS NOT PROVIDED, IT IS NOT POSSIBLE TO RULE OUT THAT POSSIBLE MISLOAD MIGHT HAVE CONTRIBUTED TO THE INFOLD. IT WAS REPORTED THAT A NEW VALVE LOADED; BUT FLUOROSCOPY VALVE LOAD INSPECTION WAS NOT PROVIDED THUS IT IS NOT POSSIBLE TO VALIDATE A GOOD LOAD. DURING THE DEPLOYMENT ATTEMPT WITH THE NEW VALVE, ANOTHER INFOLD OCCURRED. SUBSEQUENTLY, FURTHER ATTEMPTS TO IMPLANT AN EVOLUT WERE ABORTED, AND A NON-MEDTRONIC VALVE WAS IMPLANTED. UPDATED B.5, H.6 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.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: D9 H2 H3 H6 PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS RETURNED LOADED INSIDE THE DELIVERY SYSTEM. THE VALVE WAS REMOVED FROM THE DELIVERY SYSTEM AND FORWARDED TO THE SANTA ANA RETURN PRODUCT ANALYSIS LAB. THE VALVE WAS RECEIVED IN A HEART VALVE RETURN KIT JAR FULLY SUBMERGED IN A CLOUDY 0.2% GLUTARALDEHYDE SOLUTION. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE WAS RECEIVED IN A COMPRESSED STATE WITH THE FRAME SLIGHTLY DISTORTED. ALL LEAFLETS EXHIBITED SIGNS OF CREASES AND FRAME IMPRINTS. THESE CONDITIONS MAY BE ASSOCIATED WITH THE VALVE BEING CRIMPED INSIDE THE CAPSULE OF THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION. THE LEAFLETS WERE STIFF YET SLIGHTLY FLEXIBLE. AS RECEIVED, ALL LEAFLETS APPEARED PARTIALLY OPEN. A LARGE GAP WAS OBSERVED BETWEEN THE FREE MARGINS. ALL COMMISSURES APPEARED INTACT. THE VALVE WAS SUBMERGED IN BODY-TEMP (APPROXIMATELY 37 CELSIUS) SALINE. THE FRAME EXPANDED; HOWEVER, RETAINED A COMPRESSED STATE. IT IS POSSIBLE THE COMPRESSED STATE MAY BE ASSOCIATED WITH THE VALVE BEING LOADED INSIDE THE DELIVERY SYSTEM FOR AN UNKNOWN DURATION OF TIME. DUE TO THE RECEIVED CONDITION, A DEPLOYMENT SIMULATION TO EVALUATE AGAINST THE ALLEGED EVENT OF FRAME INFOLDING CANNOT BE PERFORMED. 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

    IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-34, THE VALVE WAS LOADED WITH AN OVERLAP UP TO NODE 3-4. THE VALVE WAS INITIALLY POSITIONED TOO DEEP, NECESSITATING A RECAPTURE INTO THE DELIVERY CATHETER SYSTEM (DCS). THE SECOND ATTEMPT AT POSITIONING WAS AGAIN TOO DEEP, REQUIRING A SECOND RECAPTURE. DURING THE THIRD POSITIONING ATTEMPT, AN INFOLD APPEARED OVER THE ENTIRE LENGTH OF THE VALVE. SUBSEQUENTLY, A NEW VALVE WAS LOADED INTO A NEW DCS WITH A NOTED OVERLAP TO NODE 2. THE VALVE WAS ATTEMPTED DEPLOYMENT, BUT AN INFOLD APPEARED OVER THE ENTIRE LENGTH OF THE VALVE. THIS SECOND VALVE WAS RECAPTURED INTO THE DCS AND WITHDRAWN FROM THE PATIENT. A NON-MEDTRONIC VALVE WAS SUBSEQUENTLY IMPLANTED. THE LOADING PROCESS OF EACH VALVE WAS CONDUCTED BY TWO CERTIFIED PERFUSIONISTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD. PER THE PHYSICIAN, THE PATIENT'S HORIZONTAL AORTA AND LARGE ANNULUS WITH CALCIFICATION CONTRIBUTED TO THE INFOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822872 EVOLUT FX PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVFXPLUS-34

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male