BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE HANCOCK II MITRAL 31MM

    MDR report key: 5358552 · Received January 11, 2016

    Report

    Report Number
    2025587-2016-00038
    Event Type
    Injury
    Date Received
    January 11, 2016
    Date of Event
    June 11, 2015
    Report Date
    December 22, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: VENT-INDUCED PROSTHETIC LEAFLET THROMBOSIS TREATED BY OPEN-HEART VALVE-IN-VALVE IMPLANTATION CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 21 (2015) 389¿390 CASE REPORT ¿ ADULT CARDIAC DOI:10.1093/ICVTS/IVV150 AUTHORS: CHRISTOF STAMM, MIRALEM PASIC, SEMIH BUZ AND ROLAND HETZER JUNE 11, 2015 OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    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) MAN WITH CORONARY ARTERY DISEASE, AORTIC VALVE STENOSIS AND MILD MITRAL REGURGITATION UNDERWENT AORTIC VALVE REPLACEMENT WITH A BIOPROSTHESIS AND AORTO-CORONARY BYPASS GRAFTING. THREE HOURS POSTOPERATIVELY, THE PATIENT DEVELOPED INCREASING INOTROPE DEMAND, LACTACIDOSIS AND ELEVATED LEFT ATRIAL PRESSURE. ECHOCARDIOGRAPHY DISPLAYED SEVERE MITRAL REGURGITATION WITH A CENTRAL COAPTATION DEFICIT MAINLY CAUSED BY ANNULAR DILATATION AND DISTORTION OF THE ANTERIOR LEAFLET BY MATTRESS SUTURES IN THE AORTOMITRAL CONTINUITY. LEFT VENTRICULAR (LV) CONTRACTILE FUNCTION WAS MILDLY REDUCED LEFT VENTRICULAR EJECTION FRACTION (LVEF) = 45, AND ELEVATED CREATINE KINASE LEVELS IN THE PRESENCE OF PATENT BYPASS GRAFTS SUGGESTED INTRAOPERATIVE MYOCARDIAL PROTECTION DEFICIT. THE DECISION WAS MADE TO RETURN THE PATIENT TO THE OPERATING THEATRE AND TO REPLACE THE MITRAL VALVE, AND THIS 31-MM MEDTRONIC HANCOCK II BIOPROSTHESIS WAS IMPLANTED. WEANING FROM EXTRACORPOREAL CIRCULATION WAS NOT POSSIBLE BECAUSE BIVENTRICULAR FUNCTION WAS SEVERELY IMPAIRED, AND A CENTRAL RIGHT ATRIALTO-AORTIC EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM WAS IMPLANTED. DESPITE ADEQUATE ECMO FLOW (>3.5 L/M2/MIN), THE LV APPEARED BALLOONED, AND A 20-FR VENT CATHETER WAS INSERTED VIA THE LEFT UPPER PULMONARY VEIN INTO THE LV CAVITY. THE VENT LINE WAS CONNECTED WITH THE MAIN VENOUS LINE VIA A Y-SHAPED ADAPTER WITH NO EXTRA PUMP, AND NEGATIVE PRESSURE OF 80-100 MMHG PROVIDED ADEQUATE LV DECOMPRESSION. INTRAVENOUS (I.V.) HEPARIN WAS STARTED ONCE BLEEDING HAD CEASED, AND A PARTIAL THROMBOPLASTIN TIME (PTT) >50 SECONDS WAS FIRST RECORDED 24 H AFTER ECMO INITIATION. AFTER 5 DAYS ON ECMO SUPPORT, LV FUNCTION HAD RECOVERED AND THE ECMO SYSTEM WAS EXPLANTED. HOWEVER, TRANSOESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOW SHOWED SIGNIFICANT REGURGITATION WITHIN THE MITRAL VALVE PROSTHESIS (MVP), BECAUSE THE POSTERIOR-MOST LEAFLET WAS IMMOBILE IN THE OPEN POSITION WITH EVIDENCE OF THROMBUS DEPOSITION SEEN BY ECHOCARDIOGRAPHY, MOST LIKELY CAUSED BY THE PREVIOUS TRANSVALVULAR VENT CATHETER DESPITE ADEQUATE ANTICOAGULATION. THE DECISION WAS MADE TO APPLY A BEATING HEART APPROACH FOR REVISION OF MVP IN ORDER TO AVOID ANOTHER PERIOD OF AORTIC CROSSCLAMPING. THE SURGICAL VALVE LEAFLETS WERE EXCISED AND AN EDWARDS TRANSCATHETER AORTIC VALVE WAS IMPLANTED. HAEMODYNAMICS AND PERIPHERAL ORGAN FUNCTION CONTINUED TO RECOVER, AND THE PATIENT WAS EXTUBATED, MOBILIZED AND REFERRED TO CARDIAC REHABILITATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17379 VALVE HANCOCK II MITRAL 31MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510-31H

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention