BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 24298809 · Received February 9, 2026

    Report

    Report Number
    9617601-2026-01059
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    August 22, 2025
    Report Date
    February 9, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HABERMAN D, LUPU L, CHITTURI K, ET AL. A CAUTIONARY TALE: BALLOON POSTDILATATION OF BALLOON-EXPANDABLE VALVE TO TREAT A DE GENERATED SELF-EXPANDING VALVE RESULTING IN VSD. JACC CARDIOVASC INTERV. 2025;18(24):3112-3114. DOI:10.1016/J.JCIN.2025.05.038 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO WAS PREVIOUSLY IMPLANTED WITH A MEDTRONIC 23 MM EVOLUT R TRANSCATHETER AORTIC VALVE. EIGHT YEARS LATER, THE PATIENT DEVELOPED DYSPNEA DUE TO STENOSIS AND DEGENERATION OF THE EVOLUT R BIOPROSTHESIS. DIAGNOSTIC IMAGING CONFIRMED CORRECT INDEX POSITIONING OF THE EVOLUT R WITH ¿MILD¿ UNDER-EXPANSION OF THE VALVE FRAME. SUBSEQUENTLY, DUE TO THE UNDER-EXPANSION AND HIGH TRANSVALVULAR GRADIENT (70 MM HG), A PRE-DILATION WAS PERFORMED USING A 20 MM BALLOON (NON-MEDTRONIC CORDIS), FOLLOWED BY VALVE-IN-VALVE IMPLANT OF A 23 MM NON-MEDTRONIC TRANSCATHETER VALVE (SAPIEN). AFTERWARD, A RESIDUAL GRADIENT OF 30 MM HG WAS DETECTED, PROMPTING FURTHER EXPANSION OF THE VALVE USING A 22 MM BALLOON (NON-MEDTRONIC BECTON DICKINSON), WHICH REDUCED THE GRADIENT TO 15 MM HG AT THE CONCLUSION OF THE PROCEDURE. THE FOLLOWING DAY, A PEAK GRADIENT OF 31 MM HG AND A VENTRICULAR SEPTAL DEFECT (VSD) ORIGINATING FROM THE LEFT VENTRICULAR OUTFLOW TRACT TO THE RIGHT VENTRICLE WERE BOTH DETECTED VIA ECHOCARDIOGRAPHY. TWO WEEKS LATER, THE PATIENT REPORTED WEIGHT GAIN AND LEG EDEMA, WHICH RESPONDED MODERATELY TO DIURETIC MEDICATIONS AND AN INTERVENTIONAL SOLUTION WAS PROPOSED, BUT THE PATIENT OPTED FOR PALLIATIVE CARE. AS WRITTEN BY THE AUTHORS, ¿POST-DILATATION WITH A NONCOMPLIANT BALLOON PRODUCED A ¿DOG-BONE¿ EFFECT, YIELDING OVEREXPANSION OF THE EVOLUT FRAME AT THE INFLOW, RESULTING IN VSD. A 20-MM SAPIEN VALVE AND A SMALLER POST-DILATATION BALLOON MIGHT HAVE BEEN SAFER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356724 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| R