BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLICI-T BAND

    MDR report key: 19197554 · Received April 26, 2024

    Report

    Report Number
    2025587-2024-02601
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 16, 2021
    Report Date
    April 26, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    K052970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TAMER ET AL. LATE RESULTS OF AORTIC VALVE REPAIR FOR ISOLATED SEVERE AORTIC REGURGITATION. J THORAC CARDIOVASC SURG. 2023 MAR;165(3):995-1006.E3. DOI: 10.1016/J.JTCVS.2021.04.011. EPUB 2021 APR 16. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING RESULTS OF AORTIC VALVE REPAIR FOR ISOLATED SEVERE AORTIC REGURGITATION. THE STUDY POPULATION INCLUDED 127 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 55.6 YEARS.  MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; AN UNDISCLOSED NUMBER OF PATIENTS WERE IMPLANTED WITH A MEDTRONIC SIMPLICI-T ANNULOPLASTY BAND.  DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.  AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: RECURRENT SEVERE AORTIC REGURGITATION, AORTIC STENOSIS, STROKE, PERIPHERAL EMBOLISM, MAJOR BLEEDING COMPLICATION, AND INFECTIVE ENDOCARDITIS REQUIRING INTERVENTION.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982407 SIMPLICI-T BAND HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 670100

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Life Threatening| H| R