BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 15351908 · Received September 2, 2022

    Report

    Report Number
    2025587-2022-02453
    Event Type
    Death
    Date Received
    September 2, 2022
    Date of Event
    August 8, 2021
    Report Date
    September 2, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KHAZAAL J.; ET AL. FREESTYLE AORTIC BIOPROSTHESES IN PATIENTS 60 YEARS OLD AND YOUNGER. SEMIN THORAC CARDIOVASC SURG. 2022 AUTUMN;34(3):870-877. DOI: 10.1053/J.SEMTCVS.2021.08.003. PMID: 34380081. EPUB 2021 AUG 8 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE AORTIC ROOT BIOPROSTHESIS (PMA# P970031, PRODUCT CODE: LWR). 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

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING CLINICAL OUTCOMES IN PATIENTS YOUNGER THAN 60 YEARS OF AGE IMPLANTED WITH AN AORTIC ROOT BIOPROSTHESIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 1998 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 515 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 51 YEARS. ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC FREESTYLE PORCINE AORTIC ROOT BIOPROSTHESIS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, SIX POST-OPERATIVE DEATHS OCCURRED AFTER HOSPITALIZATION AND RE-OPERATION FOR SEVERE AORTIC REGURGITATION/STENOS IS AND CARDIOGENIC SHOCK CAUSED BY FREESTYLE STRUCTURAL VALVE DETERIORATION (SVD). SVD WAS DUE TO LEAFLET DEHISCENCE, CALCIFICATION, AND STRUCTURAL FATIGUE, REQUIRING VALVE REPLACEMENT. OVERALL MORTALITY DURING 15-YEAR FOLLOW-UP WAS 36%, HOWEVER THE CAUSES/MANNER OF DEATHS DURING LONG-TERM FOLLOW-UP WERE NOT CHARACTERIZED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SEVERE AORTIC REGURGITATION/STENOSIS, REQUIRING HOSPITALIZATION AND VALVE REPLACEMENT SURGERY/TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR); STRUCTURAL VALVE DETERIORATION (SVD) FROM LEAFLET DEHISCENCE, CALCIFICATION, AND STRUCTURAL FATIGUE; ENDOCARDITIS AND PSEUDOANEURYSMS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384515 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization| R| L| D