BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 17961591 · Received October 18, 2023

    Report

    Report Number
    2025587-2023-04219
    Event Type
    Death
    Date Received
    October 18, 2023
    Date of Event
    June 22, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HALIM J, ROOIJAKKERS M, DEN HEIJER P, ET AL. ASSESSING THE NOVEL MYVAL BALLOON-EXPANDABLE VALVE WITH THE EVOLUT VALVE: A P ROPENSITY-MATCHED STUDY. J CLIN MED. 2023;12(13):4213. PUBLISHED 2023 JUN 22. DOI:10.3390/JCM12134213 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). EARLIEST APP ROVED 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. 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A PROPENSITY-MATCHED STUDY THAT COMPARED THE NON-MEDTRONIC MYVAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) SYSTEM (N = 91) WITH THE MEDTRONIC EVOLUT R/PRO TAVR SYSTEMS (N = 91). THE AUTHORS WROTE, ¿IN THE EVOLUT GROUP, ONE PATIENT DIED DURING TAVR. THIS WAS CAUSED BY LEFT MAIN CORONARY ARTERY OBSTRUCTION AFTER VALVE DEPLOYMENT.¿ NO FURTHER DETAILS WERE PROVIDED ABOUT THIS DEATH. WITHIN ONE YEAR OF TAVR, AN ADDITIONAL 11 DEATHS WERE OBSERVED. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THESE 11 DEATHS. OTHER ADVERSE EVENTS THAT OCCURRED IN EVOLUT GROUP WERE DESCRIBED AS FOLLOWS: VALVE EMBOLIZATION REQUIRING IMPLANT OF A SECOND VALVE (1 CASE), CORONARY OBSTRUCTION (2 CASES), STROKE (5 CASES), MYOCARDIAL INFARCTION (4 CASES), ACUTE KIDNEY INJURY (6 CASES), MILD PARAVALVULAR LEAK (21 CASES), MODERATE-SEVERE PARAVALVULAR LEAK (4 CASES), AND HIGH-GRADE ATRIOVENTRICULAR BLOCK NECESSITATING PERMANENT PACEMAKER IMPLANTATION (14 CASES). NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING PHYSICIAN/AUTHOR STATED THAT A MEDTRONIC VALVE DID NOT CAUSE OR CONTRIBUTE TO THE ADDITIONAL 11 DEATHS OBSERVED WITHIN ONE YEAR OF TAVR. THE PHYSICIAN/AUTHOR ALSO STATED THAT A MEDTRONIC VALVE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE OTHER ADVERSE EVENTS MENTIONED IN THE ARTICLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175230 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death