BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 6437196 · Received March 27, 2017

    Report

    Report Number
    2025587-2017-00477
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    November 23, 2016
    Report Date
    February 27, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    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. 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 CORE VALVE (SERIAL NUMBERS NOT PROVIDED). PATIENT 4: AN (B)(6) FEMALE IMPLANTED WITH A 26-MM COREVALVE WHO WAS NOTED WITH A LEFT VENTRICLE (LV) TO SUBCUTANEOUS TISSUE ASEPTIC INTRACARDIAC SHUNT, MILD AORTIC REGURGITATION, AND CARDIAC TAMPONADE DUE TO LV PERFORATION BY GUIDEWIRE (MANUFACTURER NOT PROVIDED). SURGICAL INTERVENTION WAS PERFORMED AT 90 DAYS POST TAVI. NO ADDITIONAL ADVERSE PATIENT AFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219353 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-26-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention