BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 7440700 · Received April 18, 2018

    Report

    Report Number
    2025587-2018-00902
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    March 26, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL INSPECTION REVEALED THE VALVE WAS DISTORTED AND OVAL SHAPED. A PORTION OF THE SEWING RING WAS REMOVED DURING EXPLANT. THE EXISTING LEAFLETS WERE IN THE CLOSED POSITION. ALL LEAFLETS WERE STIFF DUE TO MINERALIZATION AT INFLOW AND OUTFLOW. TISSUE DETERIORATION DUE TO VISIBLE MINERALIZATION WAS OBSERVED ON ALL LEAFLETS. TEARS WERE OBSERVED ON THE LEAFLETS OF THE LEFT CORONARY CUSP (LCC) AND NON-CORONARY CUSP (NCC). TISSUE DETERIORATION DUE TO MINERALIZATION WAS OBSERVED ON RIGHT/LEFT (RL) AND RIGHT/NON-CORONARY (RNC) COMMISSURES. THE LEFT/NON-CORONARY (LNC) COMMISSURE WAS INTACT WITH A SMALL HOLE IN THE TISSUE. PANNUS WAS OBSERVED ALONG THE INFLOW AND OUTFLOW MARGIN OF ATTACHMENTS. PANNUS WAS ALSO OBSERVED ON THE OUTFLOW OF THE REMAINING SEWING RING. PANNUS ENCAPSULATED THE RNC STENT POST ACROSS THE BASE STITCHING BETWEEN THE RNC AND LNC. PANNUS WAS ALSO PRESENT ON ALL COMMISSURES ON THE SUPERIOR COAPTIVE AREA. AN UNKNOWN AMOUNT OF PANNUS APPEARED TO HAVE BEEN REMOVED AT INFLOW AND OUTFLOW. RADIOGRAPHY SHOWED MINERALIZATION IN ALL CUSPS. CONCLUSION: REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO MINERALIZATION AND HOST TISSUE OVERGROWTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. AT THE COMPLETION OF THE ANALYSIS A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 20 YEARS AND 1 MONTH POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED. THE REASON FOR REPLACEMENT WAS DUE TO PANNUS FORMATION, CALCIFICATION AND TORN LEAFLETS (RIGHT AND LEFT CORONARY CUSPS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284561 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE DYE MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention