BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 13287003 · Received January 18, 2022

    Report

    Report Number
    2025587-2022-00132
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    November 20, 2021
    Report Date
    January 18, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LNU ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT ASSOCIATED INFECTIVE ENDOCARDITIS CASE SERIES: BROADENING THE CRITERIA FOR DIAGNOSIS IS THE NEED OF THE HOUR. BMC CARDIOVASCULAR DISORDERS. (B)(6) 2021;21(1):559. DOI: 10.1186/S12872-021-02364-0. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) ASSOCIATED INFECTIVE ENDOCARDITIS IN TWO PATIENT CASES. CASE 2: MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) MALE PATIENT WHO UNDERWENT IMPLANT OF A MEDTRONIC 34 MM EVOLUT PRO BIOPROSTHETIC VALVE (ALTHOUGH BASED ON THE SIZE WAS LIKELY AN EVOLUT R). NO UNIQUE DEVICE IDENTIFIER NUMBERS PROVIDED. EIGHT WEEKS POST-TAVR THE PATIENT PRESENTED WITH TACHYCARDIAC WITH HEART RATE OF 111 BPM. AN INITIAL ELECTROCARDIOGRAM (ECG) DID NOT SHOW ANY NEW CHANGES FROM THE BASELINE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED STABLE PROSTHETIC VALVE FUNCTION WITH NO NEW REGURGITATION. INITIAL BLOOD CULTURE SHOWED GRAM POSITIVE COCCI. A REPEAT TEE WAS SHOWED NO EVIDENCE OF VALVULAR VEGETATION. ADDITIONAL BLOOD CULTURES RESULTED IN METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). ONE WEEK AFTER PRESENTATION THE PATIENT DEVELOPED POLYMORPHIC VENTRICULAR TACHYCARDIA AND FIBRILLATION REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND DEFIBRILLATION. THE PATIENT CONTINUED TO IMPROVE HEMODYNAMICALLY AND CLINICALLY UNDER MEDICAL MANAGEMENT. BLOOD CULTURES CAME BACK NEGATIVE AND NINE DAYS AFTER PRESENTATION HE WAS DISCHARGED TO ACUTE REHAB WITH A WEARABLE CARDIOVERTER/DEFIBRILLATOR. IN REHAB, THE PATIENT DEVELOPED PERSISTENT FEVER AND SEPSIS AND WAS RE-ADMITTED. BASED ON THE CLINICAL SUSPICION OF ENDOCARDITIS, THE PATIENT UNDERWENT EXPLANT OF THE PROSTHETIC VALVE WITH SUCCESSFUL REPLACEMENT WITH A NON-MEDTRONIC PROSTHETIC VALVE. POST-OPERATIVELY THE PATIENT DEVELOPED HEMODYNAMIC INSTABILITY AND EMERGENT EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS DEPLOYED. THE PATIENT THEN DEVELOPED GASTROINTESTINAL ISCHEMIA, RENAL FAILURE AND ACUTE BLOOD LOSS WHILE ON ECMO. DUE TO HIS POOR PROGNOSIS, THE PATIENT¿S FAMILY REQUESTED COMFORT CARE. THE OUTCOME FOR THE PATIENT WAS NOT STATED BY THE AUTHORS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737714 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H| L