BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 4724787 · Received April 23, 2015

    Report

    Report Number
    2025587-2015-00466
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 3, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS AT APPROXIMATELY 2MM DEPTH WHEN IT WAS ASSESSED AT 2/3 DEPLOYMENT; BETWEEN 2/3 DEPLOYED AND FINAL RELEASE THE VALVE MOVED UP TO -2MM ON THE NON-CORONARY CUSP SIDE, ALTHOUGH IT REMAINED AT 2MM DEPTH ON LEFT CORONARY CUSP SIDE. A MILD PARAVALVULAR LEAK (PVL) APPEARED, AND THE PHYSICIAN CHOSE TO IMPLANT A SECOND VALVE, VALVE-IN-VALVE. THE FINAL DEPTH WAS APPROXIMATELY 0MM WITH A GOOD HEMODYNAMIC OUTCOME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270304 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention