BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 2111764 · Received May 24, 2011

    Report

    Report Number
    2025587-2011-00065
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. WITH THE REPORT OF PANNUS FOUND AT EXPLANT, THE REDUCED PERFORMANCE OF THE VALVE IS LIKELY ATTRIBUTED TO HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO FROM A JOURNAL ARTICLE, J ECHOCARDIOGRAPHY (2011)9:33:35, THAT THIS MECHANICAL AORTIC VALVE, IMPLANTED 13 YEARS, WAS EXPLANTED. THE PT WAS ADMITTED WITH INTERMITTENT CHEST PAIN AND ELECTROCARDIOGRAPHY ON ADMISSION REVEALED NON-SPECIFIC CHANGES, BUT ELECTROCARDIOGRAPHY DURING CHEST PAIN REVEALED SIGNIFICANT ST DEPRESSION. CORONARY ANGIOGRAPHY REVEALED NO SIGNIFICANT STENOSIS. ECHOCARDIOGRAPHY REVEALED INTERMITTENT AORTIC REGURGITATION AND INCOMPLETE CLOSURE OF THE PROSTHETIC VALVE IN DIASTOLE. AT EXPLANT, ABNORMAL PANNUS FORMULATION WAS OBSERVED AT THE LEFT VENTRICULAR SIDE OF THE PROSTHETIC VALVE. A 19-MM MOSAIC VALVE WAS IMPLANTED, AND THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THE PT WAS DISCHARGED ON THE 20TH POSTOPERATIVE DAY WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HALL PROSTHETIC HEART VALVE LWQ MEDTRONIC HEART VALVES, INC. A7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention