BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3913349 · Received July 3, 2014

    Report

    Report Number
    2025587-2014-00442
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 1, 2014
    Report Date
    August 15, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. INVESTIGATION REMAINS IN PROGRESS, ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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. A NUMBER OF FACTORS CAN AFFECT THE CREATION OF THROMBUS, INCLUDING MEDICATIONS, PERI-PROCEDURAL INJURY, AND PRE-EXISTING PATIENT CONDITIONS, AND ITS PRESENCE AND RATE OF FORMATION IS LARGELY DEPENDENT ON PATIENT CONDITION. WITH THE LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE DEVICE AND THE THROMBUS COULD NOT BE ESTABLISHED.

    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 TWO HOURS POST-IMPLANT, RIGHT HEMIPARESES AND APHASIA WERE NOTED. A THROMBECTOMY WAS PERFORMED TO REMOVE A CLOT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390307 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention