BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 16738490 · Received April 13, 2023

    Report

    Report Number
    2025587-2023-01515
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 4, 2023
    Report Date
    April 13, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: NG ET AL. VIVIV, TAVI-IN-TAVI-IN-SAVR IN A PATIENT WITH C ACNES ENDOCARDITIS. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, MARCH 7 2023, VOLUME 81, ISSUE 8, SUPPLEMENT A. 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A 62-YEAR-OLD MALE PATIENT WITH A PRIOR HISTORY OF SURGICAL AORTIC VALVE REPLACEMENT (SAVR) AND ASCENDING AORTA REPLACEMENT, AND LATER UNDERWENT A TRANSCATHETER-IN-SURGICAL AORTIC VALVE IMPLANTATION WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC. APPROXIMATELY FOUR YEARS AFTER THIS VALVE IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH ACCELERATING DYSPNEA FOLLOWED BY DECOMPENSATION INTO CARDIOGENIC SHOCK. TRANSTHORACIC ECHOCARDIOGRAM (TTE) DEMONSTRATED SEVERE AORTIC STENOSIS AND REGURGITATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A TRANSCATHETER VALVE-IN-VALVE IMPLANT OF A NON-MEDTRONIC BIOPROSTHETIC VALVE. POST-PROCEDURAL EVALUATION CONFIRMED TRACE CENTRAL AORTIC REGURGITATION AND POSITIVE CULTURES FOR ENDOCARDITIS DUE TO THE PRESENCE OF CUTIBACTERIUM ACNES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480330 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| L| R