BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 23MM AORTIC VALVE

    MDR report key: 3952266 · Received July 23, 2014

    Report

    Report Number
    2025587-2014-00507
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 16, 2014
    Report Date
    January 13, 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

    THE REPORTED INFORMATION DID NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. A VARIETY OF FACTORS CAN INFLUENCE THE ONSET OF STROKE, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. STROKE IS A KNOWN POTENTIAL ADVERSE EFFECT AS LISTED IN THE INSTRUCTIONS FOR USE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

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

    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 OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT SUBSEQUENTLY WAS REPORTED THAT NEUROLOGICAL IMAGING CONFIRMED A TRANSIENT ISCHEMIC ATTACK (TIA)/ACUTE INFARCTION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT TWO WEEKS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT EXPERIENCED A STROKE THAT WAS CONSIDERED TO BE POSSIBLY RELATED TO THE DEVICE. THE PATIENT HAD BEEN DISCHARGED FOLLOWING DEVICE IMPLANT, AND WAS RE-ADMITTED FOLLOWING THE STROKE, WHICH WAS TREATED WITH MEDICATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430195 COREVALVE 23MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-2334

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| O