BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 7690496 · Received July 16, 2018

    Report

    Report Number
    2025587-2018-01760
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    August 31, 2017
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PARK B ET AL. CLINICAL IMPLICATION OF TRANSAORTIC MITRAL PANNUS REMOVAL DURING REPEAT CARDIAC SURGERY FOR PATIENTS WITH MECHANICAL MITRAL VALVE. CIRC J. 2018 JAN 25;82(2):396-402. DOI: 10.1253/CIRCJ.CJ-17-0463. EPUB (B)(6) 2017. EARLIEST 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 THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 REGARDING THE SAFETY AND FEASIBILITY OF TRANSAORTIC MITRAL PANNUS REMOVAL IN PATIENTS WITH RHEUMATIC HEART DISEASE ON THE VENTRICULAR SIDE OF A MECHANICAL MITRAL VALVE THROUGH THE AORTIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2004 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 34 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 57 YEARS), 6 OF WHICH WERE IMPLANTED WITH A 27 MM MEDTRONIC OPEN PIVOT MECHANICAL VALVE, 4 WERE IMPLANTED WITH A 29 MM MEDTRONIC OPEN PIVOT MECHANICAL VALVE, AND 3 WERE IMPLANTED WITH A MEDTRONIC MED HALL EASY-FIT MECHANICAL HEART VALVE. NO SERIAL NUMBERS WERE PROVIDED. THE ARTICLE DEFINED AN EARLY EVENT AS ANY EVENT OCCURRING WITHIN 30 DAYS OF THE SURGERY. AMONG ALL PATIENTS, THERE WERE NO EARLY DEATHS. THERE WERE 4 LATE DEATHS: 1 DUE TO HEART FAILURE, SEPSIS FROM ENDOCARDITIS IN 1 PATIENT, 1 DUE TO CHRONIC RENAL FAILURE, AND DEATH OF UNKNOWN CAUSE IN 1 PATIENT. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, EARLY ADVERSE EVENTS INCLUDED: 2 PERMANENT PACEMAKER IMPLANTATIONS FOR HEART BLOCK AND SICK SINUS SYNDROME, 1 REOPERATION BECAUSE OF BLEEDING, AND 1 CASE OF MEDIASTINITIS. OTHER ADVERSE EVENTS INCLUDED: PANNUS FORMATION, MECHANICAL MITRAL VALVE REPLACEMENT, MITRAL VALVE PARAVALVULAR LEAKAGE AND LEAKAGE CLOSURE, ECCENTRIC MITRAL REGURGITATION, AORTIC REGURGITATION, THROMBUS, STENOSIS, HIGH TRANSPROSTHETIC MEAN PRESSURE GRADIENTS, COMPLETE IMMOBILIZATION OF ONE CUSP, DELAYED MECHANICAL VALVE LEAFLET CLOSURE, AND EXTRACORPOREAL MEMBRANE OXYGENATION FOR CARDIAC ARREST. LATE ADVERSE EVENTS NOTED IN THE ARTICLE INCLUDED: 5 CASES OF CEREBRAL HEMORRHAGE, 2 CASES OF ENDOCARDITIS (1 RESULTING IN REOPERATION AND 1 REQUIRING MEDICAL TREATMENT), 2 PERMANENT PACEMAKER IMPLANTATIONS FOR SICK SINUS SYNDROME AND 1 CASE OF MILD MITRAL PARAVALVULAR LEAKAGE. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. AMONG ALL PATIENTS THAT RECEIVED A MED HALL MECHANICAL VALVE, DEVICE MALFUNCTIONS INCLUDED: AORTIC REGURGITATION CAUSED BY ACUTE MALFUNCTION OF THE MECHANICAL MITRAL VALVE. BASED ON THE AVAILABLE INFORMATION, THESE MALFUNCTIONS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531186 MEDTRONIC HALL PROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION M7700

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR