BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 2933472 · Received January 29, 2013

    Report

    Report Number
    2025587-2013-00012
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE SEWING RING APPEARED SLIGHTLY EVERTED ADJACENT TO THE TEAR. SMALL NEEDLE HOLES IN THE SEWING RING SHOWED PLACEMENT OF IMPLANTATION SUTURES. ALL LEAFLETS WERE IN THE OPEN POSITION. ALL LEAFLETS AND COMMISSURES WERE INTACT. THE MYOCARDIAL TISSUE WAS TORN, APPROXIMATELY 9.5 MM IN LENGTH, FROM UNDER THE CLOTH BASE STITCHING IN THE RIGHT NON-CORONARY INFERIOR COAPTIVE AREA. THE TISSUE APPEARED STRETCHED ADJACENT THE TEAR, POSSIBLY DUE TO THE EVERTED SEWING RING. TISSUE REMAINED IN PLACE UNDER THE CLOTH ABOVE THE STITCHING LINE. CONCLUSION: THE CLINICAL OBSERVATION WAS CONFIRMED AND WAS CAUSED BY OPERATIONAL CONTEXT. THE VALVE WAS RECEIVED WITH THE INFLOW EDGE FLANGED, AND INDICATED THAT THE VALVE WAS EVERTED OR FOLDED TO POSSIBLY AID IN IMPLANTATION. PLEASE NOTE THAT OUR INSTRUCTIONS FOR USE STATE THE FOLLOWING: TAKE CARE NOT TO EVERT (ROLL OUTWARD) THE INFLOW END OF THE BIOPROSTHESIS WHEN SUTURING THE VALVE TO THE PATIENT'S ANNULUS. EVERSION COULD DAMAGE THE VALVE TISSUE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, WHILE SUTURING THE VALVE, THE VALVE TORE AT ITS EDGE. THE VALVE WAS EXPLANTED AND ANOTHER VALVE WAS IMPLANTED WITH NO ADDITIONAL REPORTED ADVERSE PATIENT EFFECTS. THE VALVE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39069 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA FR995

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R