BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 24296284 · Received February 9, 2026

    Report

    Report Number
    9617601-2026-01054
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    December 2, 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
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: COUTINHO HMR, DA SILVA JA, PERALTA D, ET AL. FROM THE HEART TO THE KIDNEY: A CASE REPORT OF WUNDERLICH SYNDROME FOLLOWING STRUCTURAL VALVE INTERVENTION. RADIOL CASE REP. 2025;21(2):880-884. PUBLISHED 2025 DEC 2. DOI:10.1016/J.RADCR.2025.11.002 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 UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH A MEDTRONIC 34 MM EVOLUT R VALVE. DESPITE AN UNEVENTFUL PROCEDURE, POST-PROCEDURAL ECHOCARDIOGRAPHY SHOWED MODERATE-TO-SEVERE PARAVALVULAR LEAK (PVL). ELEVEN MONTHS LATER, ¿DUE TO PERSISTENT SYMPTOMS,¿ PERCUTANEOUS PVL CLOSURE WAS ATTEMPTED USING TWO NON-MEDTRONIC VASCULAR PLUG DEVICES BUT WAS UNSUCCESSFUL, RESULTING IN A SEVERE RESIDUAL LEAK. EIGHTEEN HOURS LATER, THE PATIENT DEVELOPED RIGHT FLANK PAIN RADIATING TO THE LUMBAR REGION, AND A COMPUTED TOMOGRAPHY (CT) SCAN EXHIBITED A PERIRENAL HEMATOMA WITH RETROPERITONEAL EXTENSION, ¿DISPLACING AND COMPRESSING THE KIDNEY.¿ CONSERVATIVE TREATMENT WAS INITIATED, WHICH CONSISTED OF HYDRATION, ANALGESIA, AND CLOSE MONITORING. TWENTY-FOUR HOURS LATER, THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN AND LOW BLOOD PRESSURE. THE PATIENT WAS GIVEN THREE UNITS OF PACKED RED BLOOD CELLS AND STABILIZED. THE AUTHORS WROTE THAT SELECTIVE RENAL ARTERIOGRAPHY SHOWED NO ACTIVE BLEEDING OR VASCULAR ABNORMALITY AND CONSERVATIVE TREATMENT WAS CONTINUED. AT THE SEVENTY-TWO-HOUR MARK, CT SHOWED STABLE HEMATOMA SIZE. THE PATIENT WAS DISCHARGED AFTER SEVEN DAYS, WITH STABLE LABS AND NORMAL RENAL FUNCTION. SIX WEEKS LATER, ¿ULTRASONOGRAPHY CONFIRMED NEAR-COMPLETE HEMATOMA RESORPTION.¿ IMAGING AT THE THREE-MONTH FOLLOW-UP SHOWED MARKED REGRESSION, PRESERVED RENAL FUNCTION, AND NORMAL BLOOD PRESSURE. HOWEVER, THE PATIENT WAS ULTIMATELY REFERRED FOR SURGICAL AORTIC VALVE REPLACEMENT DUE TO PERSISTENT DYSPNEA RESULTING FROM THE RESIDUAL PVL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355469 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Life Threatening| H| R