BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 16309529 · Received February 6, 2023

    Report

    Report Number
    2025587-2023-00425
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    September 11, 2021
    Report Date
    February 6, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BROWN J.; ET AL. MIDTERM OUTCOMES OF STENTED VERSUS STENTLESS BIOPROSTHETIC VALVES AFTER AORTIC ROOT REPLACEMENT. SEMIN THORAC CARDIOVASC SURG. 2022 WINTER;34(4):1147-1155. DOI: 10.1053/J.SEMTCVS.2021.09.003. EPUB 2021 SEP 11. PMID: 34520838 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (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 COMPARING OUTCOMES BETWEEN STENTED VERSUS STENTLESS AORTIC ROOT SURGICAL REPLACEMENTS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JULY 2010 AND JUNE 2018. THE STUDY POPULATION INCLUDED 455 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 69 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 243 PATIENTS WERE IMPLANTED WITH A MEDTRONIC FREESTYLE BIOPROSTHESIS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL MEDTRONIC FREESTYLE PATIENTS, OPERATIVE MORTALITY (WITHIN 30 DAYS POST-SURGERY) WAS 6.2%, 1-YEAR SURVIVAL WAS 85.3% AND 5-YEAR SURVIVAL WAS 72%. NO FURTHER INFORMATION WAS PROVIDED ON THE CAUSES OF DEATH. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKES, TRANSIENT ISCHEMIC ATTACKS (TIAS), SEPSIS, SEVERE AORTIC REGURGITATION, RENAL FAILURE REQUIRING DIALYSIS, STRUCTURAL VALVE DETERIORATION (SVD) RESULTING IN SEVERE AORTIC INSUFFICIENCY AND STENOSIS. OVERALL, NINE PATIENTS UNDERWENT E-OPERATIONS FOR BLEEDING, INFECTIVE ENDOCARDITIS, STRUCTURAL VALVE DETERIORATION (SVD). BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    100493 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Life Threatening| R