BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG FUTURE BAND

    MDR report key: 4384660 · Received January 6, 2015

    Report

    Report Number
    2025587-2015-00030
    Event Type
    Injury
    Date Received
    January 6, 2015
    Date of Event
    November 28, 2014
    Report Date
    February 5, 2015
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    PMA / PMN Number
    K011395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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

    EVENT DESCRIPTION UPDATED. NO PRODUCT WAS RETURNED AND NO INFORMATION ON THE TRICUSPID RING WAS ABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 1

    IT WAS NOT REPORTED WHETHER THE EXPLANTED RING WOULD BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4)

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY RING WAS IMPLANTED IN A PATIENT WITH A LONGSTANDING HISTORY OF MITRAL INSUFFICIENCY AND ATRIAL FIBRILLATION. DURING THE MITRAL VALVE REPAIR, A CORONARY ARTERY BYPASS GRAFT (CABG), LIMA TO LAD, AND PULMONARY VEIN ISOLATION, LEFT ATRIAL APPENDAGE LIGATION AND AMPUTATION OF THE RIGHT ATRIAL APPENDAGE WERE PERFORMED. FOLLOWING IMPLANT OF THE RING, THE MITRAL VALVE LEAFLETS WERE NOTED TO BE COMPETENT WITH MINIMAL REGURGITATION. FIFTEEN DAYS POST IMPLANT OF THE MITRAL ANNULOPLASTY RING, THE PATIENT PRESENTED WITH HEART FAILURE. ECHOCARDIOGRAM REVEALED 4+ MITRAL REGURGITATION AND A PARTIALLY DEHISCED TRICUSPID ANNULOPLASTY RING (MANUFACTURER UNKNOWN). THE SURGEON REPORTED THERE WERE NO SIGNS OF INFECTION AND IT WAS UNKNOWN WHY THE TRICUSPID RING DEHISCED. THE PATIENT WAS TAKEN TO SURGERY AND A MITRAL VALVE REPAIR WITH DIVISION OF THE SECONDARY CHORDAE IN THE P3 SEGMENT WAS PERFORMED WITH REPLACEMENT OF THE RING WITH A 30MM 3D PROFILE RING. A 32MM 3D CONTOUR ANNULOPLASTY RING WAS IMPLANTED IN THE TRICUSPID POSITION. FOLLOWING THE IMPLANT OF BOTH ANNULOPLASTY RINGS, THERE WAS NO MITRAL OR TRICUSPID REGURGITATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FIFTEEN DAYS POST-IMPLANT, THE PATIENT WITH THIS MITRAL ANNULOPLASTY RING PRESENTED WITH HEART FAILURE AND SEVERE MITRAL REGURGITATION. IT WAS REPORTED THAT THE DEVICE SUTURES HAD ALMOST COMPLETELY DEHISCED FROM THE RING AND ANNULUS, ALTHOUGH THERE WAS NO CLEAR REASON FOR THE DEHISCENCE AND NO EVIDENCE OF INFECTION. THE RING WAS EXPLANTED AND REPLACED BY ANOTHER MEDTRONIC ANNULOPLASTY RING. DURING THE SAME PROCEDURE A MEDTRONIC ANNULOPLASTY RING WAS ALSO PLACED IN THE TRICUSPID POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6734 CG FUTURE BAND RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 638BL30

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention