BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 16924339 · Received May 12, 2023

    Report

    Report Number
    2025587-2023-02039
    Event Type
    Death
    Date Received
    May 12, 2023
    Date of Event
    November 11, 2022
    Report Date
    May 12, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: STEHLI J, ET AL. LONG-TERM VALVE DURABILITY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. HEART, LUNG AND CIRCULATION. (B)(6) 2023. ;32(2):240-246. DOI: (B)(6). EPUB (B)(6) 2022. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 THE LONG-TERM INCIDENCE OF STRUCTURAL VALVE DETERIORATION (SVD) IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). A TOTAL OF 421 PATIENTS WHO HAD A MINIMUM FOLLOW-UP OF 2 YEARS WERE INCLUDED IN THE STUDY. MEDTRONIC (COREVALVE = 256, EVOLUT R/PRO = 92) AND NON-MEDTRONIC (EDWARDS = 53, ABBOTT = 20) VALVE TYPES WERE USED IN THE STUDY. IT WAS STATED THAT THE LONGEST FOLLOW-UP TIME WAS 10 YEARS, WHILE THE MEDIAN FOLLOW-UP WAS 4.7 YEARS (RANGE OF 3.6 TO 6 YEARS). THE AUTHORS OBSERVED 130 DEATHS DURING THE TOTAL FOLLOW-UP. VALVE RELATED DEATH OCCURRED IN SIX CASES. ADDITIONALLY, THE AUTHORS WROTE, ¿ONE PATIENT DEVELOPED SVD STAGE 3 DUE TO SEVERE INTRA-PROSTHETIC AORTIC REGURGITATION. THE PATIENT DIED SHORTLY AFTER THE DIAGNOSIS WAS MADE, WITH NO POST-MORTEM AUTOPSY PERFORMED.¿ OTHER ADVERSE EVENTS THAT OCCURRED DURING FOLLOW-UP WERE DESCRIBED AS FOLLOWS: OCCURRENCE OF SVD, DECREASED LEFT VENTRICULAR EJECTION FRACTION, PARAVALVULAR AORTIC REGURGITATION/LEAK (MILD TO SEVERE), REPEAT TAVI (VALVE-IN-VALVE) OR CONVERSION TO SURGICAL AORTIC VALVE REPLACEMENT DUE TO EARLY BIOPROSTHETIC VALVE FAILURE (MODERATE-SEVERE PARAVALVULAR LEAK OR VALVE EMBOLIZATION). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042876 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death