BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-29 3F AORTIC BIO 29MM

    MDR report key: 4190587 · Received October 21, 2014

    Report

    Report Number
    3010152718-2014-00006
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 23, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MEDTRONIC 3F THERAPEUTICS, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. BASED ON THE ANALYSIS, A CONCLUSIVE CAUSE OF THE PERFORATION OF THE LEAFLET COULD NOT BE DETERMINED. THE RECEIPT CONDITION OF THE VALVE MAY HAVE ALTERED THE GROSS OBSERVATIONS. DISTORTION OF THE VALVE MAY HAVE CREATED UNEVEN LEAFLET MOVEMENT THEREBY CONTRIBUTING TO THE TEAR ON THE LEAFLET. THE PERFORATION DOES NOT APPEAR TO HAVE BEEN INDUCED DURING THE MANUFACTURING PROCEDURE, BASED ON THE DEVICE HISTORY RECORD REVIEW. THE ROOT CAUSE FOR THE REPORTED CLINICAL OBSERVATION COULD NOT BE DETERMINED. MEDTRONIC WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS RECEIVED DISTORTED IN AN OVAL SHAPE. THE VALVE TISSUE WAS DESICCATED. ALL LEAFLETS WERE STIFF BUT SLIGHTLY FLEXIBLE, EXCEPT WHERE THE TISSUE WAS DESICCATED. DISTORTION IN THE VALVE MAY HAVE CONTRIBUTED TO A PROLAPSED APPEARANCE IN LEAFLETS 1 AND 2. A LARGE PERFORATION IN THE BELLY OF LEAFLET 2 MAY BE ASSOCIATED WITH UNEVEN LEAFLET MOVEMENT THAT MAY HAVE RESULTED IN A HINGE POINT. THE TOPS OF ALL COMMISSURES HAD BEEN REMOVED DURING THE EXPLANT. A TRACE OF PANNUS REMAINED ATTACHED TO LEAFLET 3 ADJACENT TO THE 3-2 COMMISSURE. A REMNANT OF PANNUS ON THE INFLOW EXTENDED ONTO THE TUNICA OF LEAFLET 1FROM THE SEWING RING. A REMNANT OF PANNUS REMAINED ATTACHED TO THE OUTFLOW EDGE OF THE SEWING RING ADJACENT TO LEAFLET 2, EXTENDING TO THE OUTFLOW MARGIN OF ATTACHMENT. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS/INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED 18 MONTHS AFTER ITS IMPLANT DUE TO SEVERE INSUFFICIENCY. IT WAS REPORTED THAT THERE WERE OBSERVATIONS OF A VALVE LEAFLET PERFORATION AND A SMALL DETACHMENT OF THE BASE OF THE VALVE FROM THE ANNULUS. THE VALVE WAS REPLACED WITH ANOTHER MANUFACTURER¿S VALVE WITH NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666877 THV 1000-29 3F AORTIC BIO 29MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC 3F THERAPEUTICS, INC. 1000-29

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention