BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 6437681 · Received March 27, 2017

    Report

    Report Number
    2025587-2017-00479
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    November 23, 2016
    Report Date
    February 27, 2017
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ROJAS ET AL. ACQUIRED ASEPTIC INTRACARDIAC SHUNTS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT: A SYSTEMATIC REVIEW. JACC CARDIOVASC INTERV.2016 DEC 26;9(24):2527-2538. DOI: 10.1016/J.JCIN.2016.09.034. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN B3. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    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 VIA LITERATURE REGARDING IATROGENIC OR INTRA-CARDIAC SHUNTS RELATED TO FISTULA OR PERFORATION FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANT (TAVI). ALL DATA WERE COLLECTED FROM A SYSTEMATIC REVIEW OF BIOMED CENTRAL, GOOGLE SCHOLAR, PUBMED, CASE REPORTS AND OTHER SECONDARY SOURCES FROM DECEMBER 2002 TO APRIL 2016. THE STUDY POPULATION INCLUDED 31 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), 5 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). PATIENT 8: A (B)(6) YEAR OLD FEMALE IMPLANTED WITH A 26-MM COREVALVE WHO WAS NOTED WITH AN INTERVENTRICULAR ASEPTIC INTRACARDIAC SHUNTS AND MILD AORTIC REGURGITATION. A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITHIN ONE DAY OF TAVI. NO ADDITIONAL ADVERSE PATIENT AFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217432 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA MCS-P3-26-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention