BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 14350507 · Received May 10, 2022

    Report

    Report Number
    2025587-2022-01315
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 12, 2010
    Report Date
    May 10, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: WEBB ET AL. TRANSCATHETER VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHETIC HEART VALVES. CIRCULATION. 2010 APR 27;121 (16):1848-57. DOI: 10.1161/CIRCULATIONAHA.109.924613. EPUB 2010 APR 12. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE DYE), FREESTYLE (PMA# P970031, PRODUCT CODE LWR), INTACT (NOT FDA APPROVED). 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. 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 TRANSCATHETER VALVE-IN-VALVE IMPLANTATION (TAVI) FOR DECOMPENSATED BIOPROSTHETIC HEART VALVES. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS: THREE CANADIAN AND ONE BRITISH. THE STUDY POPULATION INCLUDED 24 PATIENTS WITH A MEAN AGE OF 68 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. MEDTRONIC DEVICES INCLUDED MOSAIC (MODEL 310), FREESTYLE (MODEL NOT PROVIDED), AND INTACT (MODEL 705) BIOPROSTHETIC VALVES. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE AUTHORS DID NOT CALL OUT MEDTRONIC TRANSCATHETER VALVES BY NAME OR MODEL. AMONG ALL PATIENTS, ONE DEATH OCCURRED WITHIN THIRTY DAYS AND TWO DEATHS OCCURRED DURING THE FOLLOW-UP PERIOD. THE EARLY DEATH WAS DUE TO MULTISYSTEM FAILURE AFTER A PROLONGED CARDIAC SURGERY. ONE OF THE LATE DEATHS OCCURRED AFTER A PROLONGED PROCEDURE WHICH ENTAILED A BILATERAL THORACOTOMY; THE PATIENT DIED ON DAY 45. NO FURTHER DETAILS WERE PROVIDED ON THE DEATH EVENTS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). FOUR PATIENTS HAD A PREVIOUSLY IMPLANTED AND DECOMPENSATED MEDTRONIC SURGICAL VALVE WHICH REQUIRED INTERVENTION IN THE FORM OF TRANSCATHETER VALVE-IN-SURGICAL VALVE (TAV-IN-SAV). THE PATIENT AGE WAS STATED, BUT NO OTHER DATA OR SPECIFIC PATIENT IDENTIFIERS WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT(S). PATIENT 5: AN (B)(6) PATIENT WITH A 25-MM MOSAIC MITRAL VALVE NOTED WITH STENOSIS. PATIENT 7: A (B)(6) PATIENT WITH AN 27-MM INTACT MITRAL VALVE NOTED WITH STENOSIS, MITRAL REGURGITATION, PARAVALVULAR LEAK (PVL), AND HIGH GRADIENTS OF 20 MMHG. PATIENT 15: AN (B)(6) PATIENT WITH A 21-MM FREESTYLE AORTIC VALVE NOTED WITH STENOSIS AND AORTIC REGURGITATION. PATIENT 16: AN (B)(6) PATIENT WITH A 21-MM MOSAIC AORTIC VALVE NOTED WITH STENOSIS, AORTIC REGURGITATION, AND HIGH GRADIENTS OF 37 MMHG. OTHER ADVERSE EVENTS INCLUDED: CLINICAL STROKE AT 30-DAY FOLLOW-UP; A VALVE STRUT OF THE PREVIOUSLY IMPLANTED SURGICAL VALVE EXTENDING INTO THE OUTFLOW PORTION OF THE TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872168 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Hospitalization| L| R