BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 17238454 · Received June 30, 2023

    Report

    Report Number
    2025587-2023-02591
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 29, 2022
    Report Date
    June 30, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: VEULEMANS ET AL. BIOPROSTHETIC VALVE DYSFUNCTION AND FAILURE AFTER TAVI IN BICUSPID AORTIC VALVE STENOSIS DURING ONE-YEAR FOLLOW-UP ACCORDING TO VARC-3. CLIN RES CARDIOL. 2022 DEC;111(12):1358-1366. DOI: 10.1007/S00392-022-02052-9. EPUB 2022 JUN 29. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R, EVOLUT PRO. EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 BIOPROSTHETIC VALVE DYSFUNCTION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION IN BICUSPID VALVED PATIENTS. THE STUDY POPULATION INCLUDED 109 PATIENTS, 64 OF WHOM WERE IMPLANTED WITH A MEDTRONIC EVOLUT R (N=54) OR EVOLUT PRO (N=20) BIOPROSTHETIC VALVE. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STRUCTURAL VALVE DYSFUNCTION, STROKE, CORONARY OBSTRUCTION, MAJOR BLEEDING OR VASCULAR COMPLICATION, TAMPONADE, RENAL FAILURE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, LEAFLET THROMBOSIS OR HYPO-ATTENUATING LEAFLET THICKENING (HALT), MODERATE TO SEVERE PATIENT-PROSTHESIS MISMATCH, AND MODERATE TO SEVERE PARAVALVULAR LEAK. SOME OF THESE OBSERVATIONS REQUIRED INTERVENTION IN THE FORM OF CONVERSION TO OPEN SURGERY OR REINTERVENTION. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308476 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| H