BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC FLEX

    MDR report key: 3182731 · Received June 21, 2013

    Report

    Report Number
    2134151-2013-00017
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE SURGEON COULD FIND NO VISUAL REASON FOR THE CAUSE OF THE HIGH GRADIENTS. (B)(4).

    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 FOLLOWING THE IMPLANT OF THIS MECHANICAL VALVE, ECHOCARDIOGRAPHIC EVALUATION REVEALED HIGH GRADIENTS. SUBSEQUENTLY, A NON-MEDTRONIC VALVE OF THE SAME SIZE WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE SURGEON COULD FIND NO VISUAL REASON FOR THE CAUSE OF THE HIGH GRADIENTS. THE VALVE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283395 AORTIC FLEX HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 500FA23 566969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention