BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC PORCINE HEART VALVE

    MDR report key: 5383928 · Received January 21, 2016

    Report

    Report Number
    2025587-2016-00076
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 28, 2015
    Report Date
    January 31, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: TRANSCATHETER VALVE-IN-VALVE IMPLANTATION FOR FAILED MITRAL PROSTHESIS: THE FIRST EXPERIENCE IN JAPAN. CITATION: CARDIOVASCULAR INTERVENTION AND THERAPEUTICS DECEMBER 28, 2015 (DOI 10.1007/S12928-015-0374). AUTHORS: NORIO TADA, YUSUKE ENTA, MIE SAKURAI, TATSUSHI OOTOMO AND MASAKI HATA DATE OF PUBLISH WAS 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

    A REVIEW MEDTRONIC'S GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED DEVICE SERIAL NUMBER REVEALED NO PRIOR EVENTS OR SUBMITTED REPORTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW THAT A BIOPROSTHETIC SURGICAL VALVE (25 MM)WAS IMPLANTED INTO AN 82 YEAR OLD FE MALE. THREE YEARS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, NEW YORK HEART ASSOCIATION CLASS II HEART FAILURE DUE TO MITRAL REGURGITATION WAS NOTED. MEDICATIONS WERE PRESCRIBED AS THERAPY. THE REGURGITATION INCREASED, LEADING TO PULMONARY EDEMA AND SEVERAL HOSPITA IZATIONS. EIGHT YEARS AFTER THE IMPLANT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, MEDICATIONS WERE AGAIN PRESCRIBED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED SEVERE MITRAL REGURGITATION, A PROLAPSED LEAFLET, INCREASED EJECTION FRACTION, AND POSSIBLE PULMONARY HYPERTENSION. SUBSEQUENTLY A NON MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE IN VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. SERIAL NUMBERS WERE ALSO NOT REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF AN (B)(6) FEMALE WHO WAS IMPLANTED WITH A BIOPROSTHETIC SURGICAL VALVE IN THE MITRAL POSITION. THREE YEARS POSTIMPLANT MITRAL REGURGITATION WAS NOTED. MEDICATIONS WERE PRESCRIBED AS THERAPY. THE REGURGITATION INCREASED, LEADING TO PULMONARY EDEMA AND SEVERAL HOSPITALIZATIONS. EIGHT YEARS POSTIMPLANT THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED SEVERE MITRAL REGURGITATION, A PROLAPSED LEAFLET, INCREASED EJECTION FRACTION, AND POSSIBLE PULMONARY HYPERTENSION. SUBSEQUENTLY A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR PROVIDED THE MEDTRONIC VALVE SERIAL NUMBER, DATE OF IMPLANT, AND THE PATIENT¿S WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40363 MOSAIC PORCINE HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310J25

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention