BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX VALVE

    MDR report key: 22923041 · Received August 29, 2025

    Report

    Report Number
    9617601-2025-01231
    Event Type
    Death
    Date Received
    August 29, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 9, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000762865
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: UDI#: (B)(4); PRODUCT ID: D-EVOLUTFX-34, SERIAL/LOT #: UNKNOWN, UBD: 02-OCT-2026, 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

    UPDATED: B5, 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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH PRE-EXISTING SEVERE AORTIC STENO SIS, AN AORTIC VALVE AREA OF 0.6 CM SQUARED, AND AN EJECTION FRACTION OF 20%, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH A 25 MM X 50 MM BALLOON AT NOMINAL VOLUME. THE FIRST IMPLANTATION ATTEMPT WAS VERY DIFFICULT TO POSITION, BUT THE VALVE WAS RELEASED AT A DEPTH OF 3-5 MM WITH NON-MEDTRONIC (SAFARI) GUIDEWIRE RETRACTION, TEMPORARY PACING, AND SLOW MOVEMENTS. AFTER A PROJECTION CHANGE, DISLODGE OF THE VALVE INTO THE LEFT VENTRICLE WAS NOTED. THE VALVE WAS LOCATED AT A HEIGHT OF APPROXIMATELY 20 MM WITHIN THE LEFT VENTRICLE, WITH MODERATE PERIVALVULAR LEAK. A 15 MM SNARE WAS USED ON BOTH PADDLES TO TRACTION THE VALVE. THE VALVE WAS RETURNED TO A 3 MM POSITION AND POST-DILATED. A POST-IMPLANT BALLOON DILATION WITH A 28 MM X 50 MM BALLOON WAS PERFORMED TWICE, BUT THERE WAS NO IMPROVEMENT. AFTER DEFLATING THE BALLOON AND MAINTAINING TRACTION ON THE SNARE, THE VALVE DISLODGED OUT OF THE ASCENDING AORTA AGAIN. THE PATIENT DEVELOPED A FIRST CARDIAC ARREST LASTING 3 MINUTES, WHICH WAS THEN REVERSED. AFTERWARD, AN ATTEMPT WAS MADE TO IMPLANT A SECOND PROSTHESIS, BUT THE DELIVERY DEVICE WAS VERY DIFFICULT TO PASS THROUGH THE FIRST PROSTHESIS. THIS IS DUE TO THE LOCATION THE FIRST VALVE WAS SNARED TO. DURING THE ATTEMPT TO IMPLANT THE SECOND PROSTHESIS, THE PATIENT DEVELOPED ANOTHER CARDIAC ARREST. THE DECISION WAS MADE TO RELEASE THE SECOND VALVE URGENTLY AND ADMINISTER CARDIOPULMONARY RESUSCITATION. AFTER CIRCULATION RETURNED, THE SECOND PROSTHESIS WAS AGAIN MOVED INTO THE LEFT VENTRICLE, WHERE ATTEMPTS WERE MADE TO REPOSITION IT WITH A SNARE, BUT WITHOUT SUCCESS. THE PATIENT WENT INTO CARDIAC ARREST AGAIN AND DIED. OF NOTE, DURING THE PROCEDURE THE PATIENT REQUIRED HIGH DOSE VASOPRESSOR MEDICATION AND MECHANICAL VENTILATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE IN A PATIENT WITH PRE-EXISTING SEVERE AORTIC STENO SIS, AN AORTIC VALVE AREA OF 0.6 CM SQUARED, AND AN EJECTION FRACTION OF 20%, A PRE-IMPLANT BALLOON DILATION WAS PERFORMED WITH A 25 MM X 50 MM BALLOON AT NOMINAL VOLUME. THE FIRST IMPLANTATION ATTEMPT WAS VERY DIFFICULT TO POSITION, BUT THE VALVE WAS RELEASED AT A DEPTH OF 3-5 MM WITH NON-MEDTRONIC (SAFARI) GUIDEWIRE RETRACTION, TEMPORARY PACING, AND SLOW MOVEMENTS. AFTER A PROJECTION CHANGE, DISLODGE OF THE VALVE INTO THE LEFT VENTRICLE WAS NOTED. THE VALVE WAS LOCATED AT A HEIGHT OF APPROXIMATELY 20 MM WITHIN THE LEFT VENTRICLE, WITH MODERATE PERIVALVULAR LEAK (PVL). A 15 MM SNARE WAS USED ON BOTH PADDLES TO TRACTION THE VALVE. THE VALVE WAS RETURNED TO A 3 MM POSITION AND POST-DILATED. A POST-IMPLANT BALLOON DILATION WITH A 28 MM X 50 MM BALLOON WAS PERFORMED TWICE, BUT THERE WAS NO IMPROVEMENT. AFTER DEFLATING THE BALLOON AND MAINTAINING TRACTION ON THE SNARE, THE VALVE DISLODGED OUT OF THE ASCENDING AORTA AGAIN. THE PATIENT DEVELOPED A FIRST CARDIAC ARREST LASTING 3 MINUTES, WHICH WAS THEN REVERSED. AFTERWARD, AN ATTEMPT WAS MADE TO IMPLANT A SECOND PROSTHESIS, BUT THE DELIVERY DEVICE WAS VERY DIFFICULT TO PASS THROUGH THE FIRST PROSTHESIS. THIS IS DUE TO THE LOCATION THE FIRST VALVE WAS SNARED TO. DURING THE ATTEMPT TO IMPLANT THE SECOND PROSTHESIS, THE PATIENT DEVELOPED ANOTHER CARDIAC ARREST. THE DECISION WAS MADE TO RELEASE THE SECOND VALVE URGENTLY AND ADMINISTER CARDIOPULMONARY RESUSCITATION. AFTER CIRCULATION RETURNED, THE SECOND PROSTHESIS WAS AGAIN MOVED INTO THE LEFT VENTRICLE, WHERE ATTEMPTS WERE MADE TO REPOSITION IT WITH A SNARE, BUT WITHOUT SUCCESS. THE PATIENT WENT INTO CARDIAC ARREST AGAIN AND DIED. OF NOTE, DURING THE PROCEDURE THE PATIENT REQUIRED HIGH DOSE VASOPRESSOR MEDICATION AND MECHANICAL VENTILATION. ADDITIONAL INFORMATION WAS RECEIVED THAT WITHDRAWAL OF THE FIRST DCS DID NOT CONTRIBUTE TO THE DISLODGEMENT. THE POST-IMPLANT BALLOON DILATION WAS PERFORMED DUE TO SEVERE PVL. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS VALVE EMBOLIZATION AND THE DCS COULD BE EXCLUDED AS A CONTRIBUTING CAUSE. THE PHYSICIAN INDICATED THE PATIENT'S UNDERLYING MEDICAL HISTORY CONTRIBUTED TO THE DEATH DUE TO CRITICAL AORTIC STENOSIS, A HIGH DOSE OF VASOPRESSOR MEDICATION BEFORE THE PROCEDURE, AND BAD PERFUSION. THE SECOND VALVE ALSO DISLODGED INTO THE LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837944 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTFX-34 00763000762865

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death "SEE H11...."