BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 3988608 · Received August 7, 2014

    Report

    Report Number
    2025587-2014-00548
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 13, 2012
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4). MEDWATCH # 2025587-2014-00360 JOURNAL TITLE: "PERCUTANEOUS COMPLETE REPAIR OF FAILED MITRAL VALVE PROSTHESIS: SIMULTANEOUS CLOSURE OF MITRAL PARAVALVULAR LEAKS AND TRANSCATHETER MITRAL VALVE IMPLANTATION ¿ SINGLE-CENTRE EXPERIENCE" CHAD KLIGER, MD; ROCIO ANGULO, MD; LEANDRO MARANAN, MD; ROBERT KUMAR, MD; VLADIMIR JELNIN, MD; ITZHAK KRONZON, MD; GREGORY P. FONTANA, MD; KONSTADINOS PLESTIS, MD; NIRAV PATEL, MD; GILA PERK, MD; CARLOS E. RUIZ, MD, PHD LENOX HILL HEART AND VASCULAR INSTITUTE ¿ NORTH SHORE/LIJ HEALTH SYSTEM, NEW YORK, NY, USA EUROINTERVENTION 2014; 10-ONLINE PUBLISH-AHEAD-OF-PRINT MAY 2014.

    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 A EURO-INTERVENTION JOURNAL ARTICLE REGARDING COMPLICATIONS ASSOCIATED WITH SURGICALLY IMPLANTED MITRAL VALVES FROM MARCH 2012 TO OCTOBER 2012 (ORIGINALLY REPORTED IN MEDWATCH # 2025587-2014-00360). THE SERIAL NUMBER WAS OBTAINED FOR THIS PATIENT. PARAVALVULAR LEAK (PVL) OF THIS 29MM MOSAIC MITRAL VALVE IMPLANTED SIX MONTHS WITH SEVERE STENOSIS WAS REPAIRED USING TWO OCCLUDERS VIA A TRANSAPICAL APPROACH, AND A 24MM MELODY VALVE WAS IMPLANTED VALVE-IN-VALVE. MILD TRANSVALVULAR REGURGITATION WAS NOTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. FROM MEDWATCH # 2025587-2014-00360 JOURNAL TITLE: "PERCUTANEOUS COMPLETE REPAIR OF FAILED MITRAL VALVE PROSTHESIS: SIMULTANEOUS CLOSURE OF MITRAL PARAVALVULAR LEAKS AND TRANSCATHETER MITRAL VALVE IMPLANTATION ¿ SINGLE-CENTRE EXPERIENCE" CHAD KLIGER, MD; ROCIO ANGULO, MD; LEANDRO MARANAN, MD; ROBERT KUMAR, MD; VLADIMIR JELNIN, MD; ITZHAK KRONZON, MD; GREGORY P. FONTANA, MD; KONSTADINOS PLESTIS, MD; NIRAV PATEL, MD; GILA PERK, MD; CARLOS E. RUIZ, MD, PHD LENOX HILL HEART AND VASCULAR INSTITUTE ¿ NORTH SHORE/LIJ HEALTH SYSTEM, NEW YORK, NY, USA EUROINTERVENTION 2014; 10-ONLINE PUBLISH-AHEAD-OF-PRINT MAY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464870 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310C29

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention