BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 13286998 · Received January 18, 2022

    Report

    Report Number
    2025587-2022-00131
    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. 2021 NOV 20;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. MEDTRONIC 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 1: MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A 79-YEAR-OLD MALE PATIENT WHO UNDERWENT IMPLANT OF A MEDTRONIC 29 MM EVOLUT PRO BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS PROVIDED. FIVE WEEKS POST-TAVR THE PATIENT PRESENTED WITH TACHYCARDIAC WITH HEART RATE OF 110 BPM AND AN EJECTION FRACTION OF 60-65%. INITIAL BLOOD CULTURES SHOWED GRAM POSITIVE COCCI. TWO DAYS LATER THE PATIENT DEVELOPED MOBITZ TYPE I BLOCK, WIDENED QRS, AND WIDE ESCAPE BEATS OF VARYING MORPHOLOGY. ADDITIONAL BLOOD CULTURES SHOWED METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED THICKENING IN THE POSTERIOR ASPECT OF THE AORTIC ROOT NEAR THE SITE OF THE INTERATRIAL SEPTUM, AND INCREASED PARAVALVULAR AORTIC REGURGITATION COMPARED TO THE POST-TAVR ECHOCARDIOGRAM. BASED ON HIGH SUSPICION FOR TAVR ASSOCIATED ENDOCARDITIS, THE PATIENT WAS TAKEN FOR SURGICAL EXPLORATION WHERE THE VALVE WAS EXPLANTED WITH NOTED MULTIPLE FOCI OF VEGETATION ADHERENT TO THE STENT FRAME. THE PROSTHETIC VALVE WAS SUCCESSFULLY REPLACED WITH A 27 MM NON-MEDTRONIC PROSTHETIC VALVE. FOURTEEN DAYS AFTER PRESENTATION THE PATIENT WAS DISCHARGED ON ANTIBIOTICS IN STABLE CONDITION. AT SIX-MONTH FOLLOW-UP THE PATIENT HAD A WELL-FUNCTIONING VALVE WITH NO CLINICAL SYMPTOMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737709 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Life Threatening| R| H