BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6078683 · Received November 4, 2016

    Report

    Report Number
    2025587-2016-01727
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    May 1, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RE´DA BELHAJ SOULAMI, MD, ARTICLE TITLE: COMPUTER-ASSISTED TRANSCATHETER HEART VALVE IMPLANTATION IN VALVE-IN-VALVE PROCEDURES INNOVATIONS 2016 11(3):193-200 10.1097/IMI.0000000000000259 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL NUMBERS) WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE TO EVALUATE THE FEASIBILITY OF COMPUTER GUIDANCE IN TRANSCATHETER HEART VALVE (THV) IM PLANTATION DURING VALVE-IN-VALVE PROCEDURES FOR THE TREATMENT OF DEGENERATED BIOPROSTHETIC HEART VALVES ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2014 AND OCTOBER 2014. THE STUDY POPULATION INCLUDED 9 PATIENTS, ONE WHERE THE VALVE-IN-VALVE WAS IMPLANTED INTO A MEDTRONIC MOSAIC (SERIAL NUMBER NOT PROVIDED) FOR REGURGITATION. AMONG ALL PATIENTS NO ADVERSE EVENTS AFTER THE VALVE-IN-VALVE IMPLANT IN THE COREVALVE WERE REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729533 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention