BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALUS AORTIC TISSUE VALVE

    MDR report key: 15757982 · Received November 9, 2022

    Report

    Report Number
    2025587-2022-03133
    Event Type
    Death
    Date Received
    November 9, 2022
    Date of Event
    November 19, 2021
    Report Date
    November 9, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P170006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GO S.; ET AL. STRICT CONTROL OF PHOSPHORUS CONCENTRATION OF HEMODIALYSIS PATIENTS MAY DECREASE STRUCTURAL VALVE DETERIORATION AFTER AORTIC VALVE REPLACEMENT. GEN THORAC CARDIOVASC SURG. 2022 JUN;70(6):547-552. DOI: 10.1007/S11748-021-01739-6. PMID: (B)(4). EPUB 2021 NOV 19. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: AVALUS (PMA# P170006, 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 OUTCOMES OF BIOPROSTHETIC AORTIC VALVE REPLACEMENT IN HEMODIALYSIS PATIENTS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2010 AND NOVEMBER 2019. THE STUDY POPULATION INCLUDED 61 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 73 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; ONE PATIENT WAS IMPLANTED WITH A MEDTRONIC AVALUS SURGICAL BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 21 DEATHS OCCURRED, DUE TO COLITIS, PNEUMONIA, RESPIRATORY DISEASES, SEPSIS, OTHER UNCHARACTERIZED INFECTIONS, CANCER, GASTROINTESTINAL COMPLICATIONS, AND OTHER UNCHARACTERIZED CAUSES OF DEATH. TWO LATE FOLLOW-UP DEATHS WERE NOTED TO BE VALVE-RELATED, HOWEVER NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH ONE OF THE VALVE-RELATED DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STRUCTURAL VALVE DETERIORATION (SVD) RESULTING IN AORTIC STENOSIS, ATRIAL FIBRILLATION AND OTHER CARDIAC CONDUCTION DISTURBANCES, WITH ONE PATIENT REQUIRING PERMANENT PACEMAKER IMPLANTATION. 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
    2442733 AVALUS AORTIC TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 40017

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death