BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 8297739 · Received February 1, 2019

    Report

    Report Number
    2025587-2019-00412
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    November 28, 2018
    Report Date
    February 1, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CAUGHRON H ET AL. REPEAT PULMONARY VALVE REPLACEMENT: SIMILAR INTERMEDIATE-TERM OUTCOMES WITH SURGICAL AND TRANSCATHETER PROCEDURES. JACC CARDIOVASC INTERV. 2018 DEC 24;11(24):2495-2503. DOI: 10.1016/J.JCIN.2018.07.042. EPUB 2018 NOV 28. 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. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). 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 A COMPARISON OF THE 30-DAY, 1-YEAR, AND 3-YEAR ECHOCARDIOGRAPHIC FINDINGS AND CLINICAL OUTCOMES OF TRANSCATHETER PULMONARY VALVE-IN-VALVE REPLACEMENT AND REPEAT SURGICAL PULMONARY VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2007 AND AUGUST 2017. THE STUDY POPULATION INCLUDED 66 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 30 YEARS), 20 OF WHICH WERE IMPLANTED WITH A MEDTRONIC MELODY BIOPROSTHETIC VALVE, 9 WERE IMPLANTED WITH A MEDTRONIC CONTEGRA VALVED CONDUIT, 15 WERE IMPLANTED WITH EITHER A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE OR A MEDTRONIC HANCOCK BIOPROSTHETIC VALVE, AND 9 WERE IMPLANTED WITH A MEDTRONIC FREESTYLE BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ONE INTRA-PROCEDURAL DEATH OCCURRED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THIS DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: DEGENERATED PULMONARY BIOPROSTHESIS DUE TO STENOSIS, REGURGITATION, COMBINATION OF BOTH, OR PARAVALVULAR LEAKAGE REQUIRING TRANSCATHETER PULMONARY VALVE-IN-VALVE REPLACEMENT OR REPEAT SURGICAL PULMONARY VALVE REPLACEMENT, NEW PERMANENT PACEMAKER IMPLANTATION, NEW ONSET ATRIAL FIBRILLATION OR FLUTTER, MAJOR STROKE, POST-OPERATIVE INFECTION, REPEAT SURGICAL INTERVENTION/PULMONARY VALVE PROCEDURE WITHIN 2 WEEKS, 1-YEAR, AND 3-YEARS POST IMPLANT, DEEP VEIN THROMBOSIS, VASCULAR STENT PLACEMENT, CONDUIT THROMBUS, ENDARTERECTOMY, MAJOR VASCULAR COMPLICATIONS AND LIFE-THREATENING/MAJOR BLEEDING, MODERATE-SEVERE PULMONARY REGURGITATION, MODERATE RIGHT VENTRICLE DYSFUNCTION, AND REDUCED LEFT VENTRICULAR EJECTION FRACTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90243 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 305_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention