BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 4182520 · Received October 17, 2014

    Report

    Report Number
    2025587-2014-00774
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    March 12, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: POTENTIAL FACTORS THAT CAN INFLUENCE VALVE DISLODGEMENT INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS AND COMPLIANCE OF THE NATIVE ANATOMY, AND OTHER FACTORS. IN THIS CASE IT WAS REPORTED THAT THE DISLODGEMENT WAS MOST LIKELY DUE TO PATIENT ANATOMY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE DISLODGED OUT OF THE TARGETED POINT OF DEPLOYMENT POSITION. THE PHYSICIAN LEFT THE VALVE IN THE ASCENDING AORTA AND SUBSEQUENTLY SUCCESSFULLY IMPLANTED A SECOND VALVE OF THE SAME MODEL AND SIZE. NO SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE PHYSICIAN STATED THAT THE DISLODGEMENT MAY HAVE BEEN DUE TO PATIENT ANATOMY AND THAT THE PATIENT HAD A POTENTIALLY FUNCTIONAL BICUSPID VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660553 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MCS-P3-31-AOA, (B)(4)