BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3940919 · Received July 17, 2014

    Report

    Report Number
    2025587-2014-00483
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    September 19, 2014
    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

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE REPORTED PARAVALVULAR LEAK (PVL) THAT REQUIRED REINTERVENTION COULD POSSIBLY BE RELATED TO PATIENT ANATOMY, VALVE POSITIONING OR IMPLANT TECHNIQUE. IMPLANT TECHNIQUE IS OFTEN DEPENDENT ON PATIENT ANATOMY. PARAVALVULAR LEAK IS A POTENTIAL ADVERSE EVENT PER THE COREVALVE IFU. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL FACTORS THAT CAN INFLUENCE THE PRESENCE PARAVALVULAR LEAK INCLUDE 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. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD TORTUROUS ANATOMY, WHICH MIGHT HAVE CONTRIBUTED TO THE INACCURATE DELIVERY. HOWEVER, THE ROOT CAUSE FOR THIS REPORT COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE.

    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 IMPLANT THIS TRANSCATHETER BIOPROSTHETIC VALVE WAS PLACED TOO LOW, WITH RESULTANT SEVERE PARAVALVULAR LEAK. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY. A SECOND VALVE WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420137 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 00081 YR Required Intervention