BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3870565 · Received June 12, 2014

    Report

    Report Number
    2025587-2014-00377
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, THE REPORTED POSITIONING ISSUE THAT REQUIRED REINTERVENTION COULD POSSIBLY BE RELATED TO PATIENT ANATOMY AND/OR IMPLANT POSITION. POSITIONING IS DEPENDENT ON PATIENT ANATOMY AS WELL AS USER TECHNIQUE. POTENTIAL FACTORS THAT CAN INFLUENCE IMPLANT POSITION INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL AND COMPLIANCE OF THE AORTA AND NATIVE VESSELS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE ROOT CAUSE FOR THIS REPORT COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE FIRST VALVE WAS NOT FULLY DEPL OYED AND IT WAS FELT THAT THE ANGLE OF IMPLANTATION WAS SUBOPTIMAL IN THE LEFT CORONARY REGION. THE VALVE COULD NOT BE RETRIEVED FROM THE PATIENT AND WAS DEPLOYED IN THE AORTIC ARCH. A SECOND VALVE WAS IMPLANTED SUCCESSFULLY WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348011 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention