BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE HANCOCK II MITRAL 31MM

    MDR report key: 5655019 · Received May 13, 2016

    Report

    Report Number
    2025587-2016-00726
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DAGNEGÅRD H ET AL. VENTRICULAR SEPTAL PERFORATION CAUSED BY THE STRUT OF A MITRAL VALVE BIOPROSTHESIS. ANN THORAC SURG 2016 MAR;101:1164¿6. DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 VIA LITERATURE REVIEW THAT A (B)(6) FEMALE PATIENT PRESENTED WITH ENDOCARDITIS OF THE NATIVE MITRAL VALVE (BLOOD CULTURES POSITIVE FOR STAPHYLOCOCCUS LUGDUNENSIS). IN SURGERY PORTIONS OF THE VALVE LEAFLETS NOTED WITH VEGETATION WERE RESECTED, AND A MEDTRONIC 31-MM HANCOCK II MITRAL BIOPROSTHESIS (SERIAL NUMBER NOT PROVIDED) WAS IMPLANTED. ROUTINE INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED NORMAL BIOPROSTHESIS FUNCTION AND NO LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. AFTER 3 DAYS OF GENERAL PROGRESS, THE PATIENT DEVELOPED DYSPNEA AND PERIPHERAL EDEMA. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) SHOWED PERFORATION OF THE VENTRICULAR SEPTUM ORIGINATING BELOW THE RIGHT CORONARY CUSP, WHERE THE CORRESPONDING STRUT OF THE BIOPROSTHESIS PROTRUDED INTO THE DEFECT. THE BIOPROSTHESIS WAS NOTED AS FUNCTIONING WELL AND THE RIGHT VENTRICLE WAS NOT DILATED. AT 6 DAYS POST-IMPLANT, THE PATIENT UNDERWENT A REOPERATION WHERE IT WAS CONFIRMED THAT THE BIOPROSTHESIS VALVE STRUT HAD ERODED INTO THE MUSCULAR VENTRICULAR SEPTUM BELOW THE RIGHT AORTIC CUSP. AFTER REMOVAL OF THE BIOPROSTHESIS, PLEDGETED SUTURES WERE PLACED TO SECURE A BOVINE PERICARDIAL PATCH OVER THE DEFECT AND A NEW 27-MM MECHANICAL PROSTHESIS (BRAND/MODEL/SERIAL NUMBER NOT PROVIDED) WAS IMPLANTED. PERIOPERATIVE TEE SHOWED A MINIMAL RESIDUAL LEAK OVER THE SEPTUM AND TTE SHOWED A MINIMAL RESIDUAL VENTRICULAR SEPTAL DEFECT, WHIC H WAS ACCEPTED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. AT 7 DAYS POST-IMPLANT A PERMANENT PACEMAKER WAS IMPLANTED TO ADDRESS ATRIAL FIBRILLATION. SEVEN MONTHS POST-IMPLANT THE PATIENT WAS MONITORED BY A CARDIOLOGIST WITH DAILY ACTIVITY LEVEL CONTINUING TO PROGRESS. THE AUTHORS CAUTIONED THAT APPROPRIATE PROSTHESIS SIZE SELECTION AND ORIENTATION ARE CRITICAL TO ALLOW FOR ADEQUATE HEMODYNAMIC PERFORMANCE WHILE AVOIDING DISTENDING THE ANNULUS AND POSSIBLE SEPTAL WALL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308721 VALVE HANCOCK II MITRAL 31MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510-31H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R