BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6196665 · Received December 21, 2016

    Report

    Report Number
    2025587-2016-02062
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 3, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169008144
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    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 · 1

    MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVED ROOT, THERE WAS AN ANEURYSM OF THE LEFT CORONARY CUSP OF THE DEVICE. THE PHYSICIAN SURGICALLY REPAIRED THE DEVICE CUSP WITH A PATCH. THE PHYSICIAN COMMENTED THAT THE WALLS AND VALVE OF THE DEVICE "LOOKED PRISTINE," AND THEREFORE REMAINED IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843584 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995 00643169008144

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention