BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 5128670 · Received October 5, 2015

    Report

    Report Number
    2025587-2015-01041
    Event Type
    Injury
    Date Received
    October 5, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT RETURNED. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILE. THE PATIENT WEIGHT WAS UNABLE TO BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE; A SECOND VALVE WAS IMPLANTED FOR SEVERE PARAVALVULAR REGURGITATION, HOWEVER, THE SECOND VALVE DID NOT REDUCE THE (PVL). A NON-MEDTRONIC VASCULAR PLUG WAS IMPLANTED REDUCING THE PVL TO MODERATE. NO FURTHER TREATMENT WAS PRESCRIBED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658331 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention