BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4243957 · Received November 11, 2014

    Report

    Report Number
    2025587-2014-00879
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    November 7, 2014
    Report Date
    December 18, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT DEVICE- OR PATIENT-IDENTIFYING INFORMATION, IT COULD NOT BE DETERMINED IF THIS COMPLAINT HAD PREVIOUSLY BEEN REPORTED. A SEPARATE REPORT HAS BEEN FILED FOR THE OTHER DEVICE EXPLANT REPORTED BY THE PHYSICIAN. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. WITH THE LIMITED RECEIVED INFORMATION, A ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. PSEUDOANEURYSM IS A KNOWN POTENTIAL ADVERSE EVENT FOR THIS DEVICE. MEDTRONIC WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR SIMILAR EVENTS SHOULD THEY OCCUR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A PHYSICIAN REPORTED EXPLANTING TWO AORTIC ROOT BIOPROSTHESES DUE TO PSEUDOANEURYSMS SOMETIME SEVERAL YEARS PREVIOUS. NO ADDITIONAL INFORMATION WAS IMMEDIATELY AVAILABLE. THE PHYSICIAN INDICATED HE WOULD ATTEMPT TO LOCATE ADDITIONAL DETAILS REGARDING THE DEVICES AND PATIENT OUTCOMES. THE EVENT DATE REPORTED HERE IS THE DATE THAT THE PHYSICIAN PROVIDED THE INFORMATION TO MEDTRONIC; THE ACTUAL DATE OF EXPLANT IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725598 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention