BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 11238657 · Received January 27, 2021

    Report

    Report Number
    2025587-2021-00287
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    July 29, 2020
    Report Date
    January 27, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LEPAGE-MIREAULT G ET AL. A CASE OF TAVR COMPLICATED BY SEVERE FUNCTIONAL MITRAL REGURGITATION. CAN J CARDIOL. 2020 DEC;36( 12):1977.E13-1977.E15. DOI: 10.1016/J.CJCA.2020.07.238. EPUB 2020 JUL 29. EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING A (B)(6) YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF SEVERE AORTIC STENOSIS, PERCUTANEOUS CORONARY INTERVENTION, PAROXYSMAL ATRIAL FIBRILLATION, CONCENTRIC LEFT VENTRICULAR HYPERTROPHY, AND MILD MITRAL REGURGITATION (MR) WHO UNDERWENT ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). PRIOR TO VALVE IMPLANTATION, LOW BLOOD PRESSURE WAS NOTED (APPROXIMATELY 100 MM HG). A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH AN 18 MM NON-MEDTRONIC BALLOON. AFTERWARD, A 26 MM MEDTRONIC EVOLUT PRO TRANSCATHETER VALVE (SERIAL NUMBER NOT PROVIDED) WAS IMPLANTED AND WAS FOLLOWED BY A POST-IMPLANT BAV WITH A 22 MM NON-MEDTRONIC BALLOON. SUBSEQUENTLY, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE DECREASED TO THE 80S. NOREPINEPHRINE TREATMENT WAS INITIATED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED MODERATE PARAVALVULAR LEAK (PVL), INCOMPLETE APPOSITION OF THE EVOLUT PRO TO THE HEAVILY CALCIFIED NATIVE VALVE, AND NEW SEVERE MR WITH NON-COAPTATION OF THE LEAFLETS. FURTHERMORE, TEE RULED OUT MITRAL VALVE IMPINGEMENT AND MITRAL APPARATUS INJURY BY THE EVOLUT PRO. IT WAS THOUGHT THE SEVERE MR WAS LIKELY CAUSED BY HYPOTENSION AND LEFT VENTRICULAR DILATATION OCCURRING DURING THE DEPLOYMENT OF THE EVOLUT PRO AND WAS WORSENED BY PVL AND VOLUME INFUSION. A NON-MEDTRONIC VENTRICULAR SUPPORT DEVICE WAS PERCUTANEOUSLY INSERTED TO TREAT THE LEFT VENTRICULAR DILATATION AND MR. THE MR WAS REDUCED TO MODERATE AND THE CARDIOGENIC SHOCK RESOLVED. ONE DAY FOLLOWING TAVR, REPEAT TEE SHOWED A DECREASED LEFT VENTRICULAR CAVITY, MILD MR, AND MODERATE PVL. THE VENTRICULAR SUPPORT DEVICE WAS REMOVED WITH NO CHANGE IN MR SEVERITY AND LEFT VENTRICULAR SIZE. THEN PVL CLOSURE WAS PERFORMED WITH AN 8 MM NON-MEDTRONIC VASCULAR PLUG. THREE MONTHS FOLLOWING TAVR, TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED TRACE MR AND NO PVL. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134875 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening| R