BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3905085 · Received July 1, 2014

    Report

    Report Number
    2025587-2014-00430
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PARAVALVULAR LEAK (PVL) THAT REQUIRED REINTERVENTION WAS LIKELY RELATED TO 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. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED SLIGHTLY HIGH, RESULTING IN MODERATE PARAVALVULAR LEAK (PVL). SUBSEQUENTLY, ANOTHER VALVE WAS IMPLANTED VALVE IN VALVE WITH MILD PARAVALVULAR LEAK. NO TREATMENT WAS PRESCRIBED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384027 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention