BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 8145278 · Received December 9, 2018

    Report

    Report Number
    2025587-2018-03363
    Event Type
    Death
    Date Received
    December 9, 2018
    Date of Event
    September 3, 2018
    Report Date
    December 9, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169002135
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 900SFC28 SERIAL/LOT #: (B)(4), UBD: 11-MAY-2023, UDI#: (B)(4), PMA/510(K) #: K093903. PRODUCT ID: 800SC28 SERIAL/LOT #: (B)(4), UBD: 03-APR-2023, UDI#: (B)(4), PMA/510(K) #: K083683. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SIX DAYS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, TRICUSPID ANNULOPLASTY RING AND MITRAL ANNULOPLASTY BAND, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE MEDTRONIC PRODUCTS OR THEIR FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984822 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995-23 00643169002135

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death