BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 23295319 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-02012
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    May 2, 2025
    Report Date
    October 14, 2025
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BASHIR ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT FOR AORTIC REGURGITATION IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES: AN INSTITUTIONAL EXPERIENCE. J SOC CARDIOVASC ANGIOGR INTERV. 2025 MAY 2;4(7):103662. DOI: 10.1016/J.JSCAI.2025.103662. 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 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR AORTIC REGURGITATION IN SEVEN PATIENTS WITH A PREVIOUSLY IMPLANTED LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE SEVEN PATIENTS PREDOMINATE GENDER WAS MALE AND MEAN AGE WAS 68.6 YEARS OLD. PATIENT 1: A 67-YEAR-OLD MALE PATIENT WAS IMPLANTED WITH A MEDTRONIC 34-MM EVOLUT R BIOPROSTHETIC VALVE. FOLLOWING DEPLOYMENT, THE VALVE SLOWLY MIGRATED INTO THE LEFT VENTRICLE RESULTING IN SEVERE AORTIC REGURGITATION AND HEMODYNAMIC INSTABILITY. THE VALVE WAS THEN SNARED AND MANEUVERED INTO GOOD POSITION WITHIN THE AORTIC ANNULUS. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED MILD PARAVALVULAR REGURGITATION. PATIENT 2: A 70-YEAR-OLD FEMALE PATIENT WAS IMPLANTED WITH A MEDTRONIC 29-MM EVOLUT PRO+ BIOPROSTHETIC VALVE. FOLLOWING DEPLOYMENT IN A LOW POSITION, THE VALVE MIGRATED INTO THE LEFT VENTRICLE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MODERATE PARAVALVULAR LEAK AND MILD AORTIC REGURGITATION. THE VALVE WAS SNARED AND MANEUVERED UNSUCCESSFULLY INTO THE ASCENDING AORTA. A SECOND EVOLUT PRO+ VALVE WAS THEN SUCCESSFULLY IMPLANTED. PATIENT 6: A 79-YEAR-OLD MALE PATIENT WAS IMPLANTED WITH A MEDTRONIC 34-MM EVOLUT FX BIOPROSTHETIC VALVE. THERE WERE NO PROCEDURAL COMPLICATIONS. HOWEVER, THE VALVE WAS FOUND TO HAVE MILD PARAVALVULAR LEAK AT DISCHARGE CHECK. AMONG ALL PATIENTS, THREE DEATHS OCCURRED WITHIN 30 DAYS OF IMPLANT; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. OTHER CLINICAL OBSERVATIONS DURING FOLLOW-UP INCLUDED THREE PATIENTS WITH GASTROINTESTINAL BLEEDING AND ONE PATIENT WITH CONGESTIVE HEART FAILURE. THESE OBSERVATIONS WERE NOT ASSOCIATED WITH A SPECIFIC PATIENT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992607 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVPROPLUS-29

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Life Threatening| H| R