BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 23042693 · Received September 12, 2025

    Report

    Report Number
    9617601-2025-01430
    Event Type
    Death
    Date Received
    September 12, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    UDI-DI
    00763000655440
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5, D6A, 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.

    Additional Manufacturer Narrative · 0

    UPDATED 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

    CONTINUATION OF D10: PRODUCT ID D-EVPROP34 (LOT: 0012443478); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE ; EXPLANT DATE PRODUCT ID D-EVPROP34 (LOT: 0012443478); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVPROPLUS-34 (K954748); 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, THE VALVE INFOLDED DUE TO SEVERE LEAFLET CALCIFICATION, WITH AN AGASTON SCORE GREATER THAN 4000. PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 25MM BALLOON. THE INFOLDED VALVE WAS IDENTIFIED AT 80% DEPLOYMENT, REMOVED, AND REPLACED WITH A NEW 34MM VALVE AND DELIVERY SYSTEM. PHYSICIANS PERFORMED ANOTHER BALLOON AORTIC VALVULOPLASTY WITH A 28MM BALLOON AND IMPLANTED THE SECOND 34MM VALVE. DISSECTION WAS OBSERVED AT THE CORONARY AND SINOTUBULAR JUNCTION LEVELS. THE PATIENT SUBSEQUENTLY DIED. ADDITIONAL INFORMATION WAS RECEIVED THAT A PROCEDURAL DELAY DID NOT OCCUR DIRECTLY AS A RESULT OF THE INFOLD, BUT IT TOOK 5-10 MINUTES TO LOADER ANOTHER VALVE. PER THE PHYSICIAN, THE PATIENT'S SEVERE LEAFLET CALCIFICATION WITH POSSIBLE FUSION OF LEAFLETS CONTRIBUTED TO THE INFOLD. THE DEATH OCCURRED THE DAY OF THE PROCEDURE AND THE CAUSE WAS ANNULAR DISSECTION THAT THE PHYSICIAN ATTRIBUTED TO AGGRESSIVE BALLOONING, NOT THE MEDTRONIC VALVES OR DELIVERY CATHETER SYSTEMS (DCS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE, THE VALVE INFOLDED DUE TO SEVERE LEAFLET CALCIFICATION, WITH AN AGASTON SCORE GREATER THAN 4000. PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 25MM BALLOON. THE INFOLDED VALVE WAS IDENTIFIED AT 80% DEPLOYMENT, REMOVED, AND REPLACED WITH A NEW 34MM VALVE AND DELIVERY SYSTEM. PHYSICIANS PERFORMED ANOTHER BALLOON AORTIC VALVULOPLASTY WITH A 28MM BALLOON AND IMPLANTED THE SECOND 34MM VALVE. DISSECTION WAS OBSERVED AT THE CORONARY AND SINOTUBULAR JUNCTION LEVELS. THE PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026235 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVPROPLUS-34 00763000655440

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death SEE H11.