BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22462329 · Received July 9, 2025

    Report

    Report Number
    2025587-2025-04872
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 12, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000822170
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012685678); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTFX-26 (K060687); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025, DATE SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX DCS; PRODUCT ID D-EVOLUTFX-2329 (LOT: 0012468075); PRODUCT TYPE: 0195-HEART VALVES; 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: B5, D3, D4, H4, H6. 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 PRIOR TO THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH AN ANNULUS PERIMETER OF 73.0 MM, A MEMBRANOUS SEPTUM LENGTH OF 1.5 MM, AND A SINUS OF VALSALVA OF APPROXIMATELY 29 MM, UPON FLUOROSCOPIC INSPECTION OF THE VALVE LOAD, A FRAME NODE OVERLAP INVOLVING THE 3.5 NODE WAS OBSERVED. SUBSEQUENTLY, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 22 MM BALLOON. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE THEN INSERTED INTO THE PATIENT. AT 80% DEPLOYMENT, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. OF NOTE, ANGIOGRAPHY DID NOT CLEARLY SHOW THE INFOLDING LINE. DESPITE THIS, ECHOCARDIOGRAPHY AND HYPOTENSION CONFIRMED THE INFOLD. THE VALVE WAS RECAPTURED; HOWEVER, THE HYPOTENSION DID NOT RESOLVE. SEVERE AORTIC REGURGITATION AND MITRAL REGURGITATION WERE NOTED, LEADING TO WORSENED HYPOTENSION AND HEMODYNAMIC INSTABILITY. CARDIOPULMONARY ARREST (CPA) MANAGEMENT WAS REQUIRED. EXTRACORPOREAL MEMBRANE OXYGENATION WAS INITIATED TO STABILIZE BLOOD PRESSURE AND A DOWNSIZED 26 MM VALVE WAS INSERTED INTO THE PATIENT. ALTHOUGH SLIGHT UNDER-EXPANSION WAS OBSERVED, DEPLOYMENT WAS BETTER COMPARED TO THE FIRST VALVE. VALVE FUNCTION WAS CONFIRMED, AND A FULL RELEASE WAS PERFORMED AT A DEPTH OF 3 MM ON THE NON-CORONARY CUSP AND 3 MM ON THE LEFT CORONARY CUSP. AFTER FULL RELEASE, COMPLETE HEART BLOCK (CHB) WAS OBSERVED. UPON EXITING THE OPERATING ROOM, THE PATIENT'S LIMBS WERE MOVING, BUT THEY DID NOT REGAIN CONSCIOUSNESS. OF NOTE, DURING THE CPA PERIOD WHILE ECMO WAS BEING INITIATED, THERE WAS A BRIEF DURATION OF CEREBRAL ISCHEMIA. THE ISCHEMIA RAISED SUSPICION FOR CEREBRAL INFARCTION. AS A RESULT, A COMPUTED TOMOGRAPHY SCAN WAS PLANNED. ADDITIONALLY, A PERMANENT PACEMAKER IMPLANT PROCEDURE HAS BEEN PLANNED TO TREAT THE CHB. THE PATIENT'S BLOOD PRESSURE STABILIZED AND ECMO WAS DISCONTINUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH AN ANNULUS PERIMETER OF 73.0 MM, A MEMBRANOUS SEPTUM LENGTH OF 1.5 MM, AND A SINUS OF VALSALVA OF APPROXIMATELY 29 MM, UPON FLUOROSCOPIC INSPECTION OF THE VALVE LOAD, A FRAME NODE OVERLAP INVOLVING THE 3.5 NODE WAS OBSERVED. SUBSEQUENTLY, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 22 MM BALLOON. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE THEN INSERTED INTO THE PATIENT. AT 80% DEPLOYMENT, AN INFOLD WAS OBSERVED IN THE VALVE FRAME. OF NOTE, ANGIOGRAPHY DID NOT CLEARLY SHOW THE INFOLDING LINE. DESPITE THIS, ECHOCARDIOGRAPHY AND HYPOTENSION CONFIRMED THE INFOLD. THE VALVE WAS RECAPTURED; HOWEVER, THE HYPOTENSION DID NOT RESOLVE. SEVERE AORTIC REGURGITATION AND MITRAL REGURGITATION WERE NOTED, LEADING TO WORSENED HYPOTENSION AND HEMODYNAMIC INSTABILITY. CARDIOPULMONARY ARREST (CPA) MANAGEMENT WAS REQUIRED. EXTRACORPOREAL MEMBRANE OXYGENATION WAS INITIATED TO STABILIZE BLOOD PRESSURE AND A DOWNSIZED 26 MM VALVE WAS INSERTED INTO THE PATIENT. ALTHOUGH SLIGHT UNDER-EXPANSION WAS OBSERVED, DEPLOYMENT WAS BETTER COMPARED TO THE FIRST VALVE. VALVE FUNCTION WAS CONFIRMED, AND A FULL RELEASE WAS PERFORMED AT A DEPTH OF 3 MM ON THE NON-CORONARY CUSP AND 3 MM ON THE LEFT CORONARY CUSP. AFTER FULL RELEASE, COMPLETE HEART BLOCK (CHB) WAS OBSERVED. UPON EXITING THE OPERATING ROOM, THE PATIENT'S LIMBS WERE MOVING, BUT THEY DID NOT REGAIN CONSCIOUSNESS. OF NOTE, DURING THE CPA PERIOD WHILE ECMO WAS BEING INITIATED, THERE WAS A BRIEF DURATION OF CEREBRAL ISCHEMIA. THE ISCHEMIA RAISED SUSPICION FOR CEREBRAL INFARCTION. AS A RESULT, A COMPUTED TOMOGRAPHY SCAN WAS PLANNED. ADDITIONALLY, A PERMANENT PACEMAKER IMPLANT PROCEDURE HAS BEEN PLANNED TO TREAT THE CHB. THE PATIENT'S BLOOD PRESSURE STABILIZED AND ECMO WAS DISCONTINUED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT AFTER THE INFOLD WAS IDENTIFIED IN THE FIRST VALVE (29MM), HYPOTENSION AND SEVERE REGU RGITATION LED TO HEMODYNAMIC INSUFFICIENCY AND THEN TO SHOCK. PER THE PHYSICIAN, THE INFOLD IN THE VALVE FRAME WAS THE CAUSE. THE SIZE OF THE BALLOON USED FOR THE PRE-IMPLANT BALLOON DILATION WAS INCREASED FROM THE SIZE USED INITIALLY AND THE SMALLER VALVE (26MM) WAS USED. A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE EVENTS IN THIS CASE. COMPUTED TOMOGRAPHY CONFIRMED A STROKE HAD OCCURRED. THE PHYSICIAN NOTED THE STROKE WAS NOT RELATED TO A MEDTRONIC DEVICE, RATHER THE TIME IT TOOK FOR ECMO TO BEINITIATED. IT WAS FURTHER NOTED NO TREATMENT WAS ADMINISTERED TO ADDRESS THE STROKE, BUT IT WAS NOTED THE PATIENT'S SYMPTOMS RESOLVED APPROXIMATELY FIVE DAYS FOLLOWING ONSET. ADDITIONALLY, A PERMANENT PACEMAKER WAS IMPLANTED TO TREAT THE CHB ON THE SEVENTH POST-OPERATIVE DAY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SLIGHT UNDER-EXPANSION OBSERVED ON THE SECOND VALVE WAS AN INCREASE FROM THE EXPANSION OF THE FIRST VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129214 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-29 00763000822170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R SEE H11...