BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10693252 · Received October 16, 2020

    Report

    Report Number
    2025587-2020-03139
    Event Type
    Death
    Date Received
    October 16, 2020
    Date of Event
    November 7, 2019
    Report Date
    October 16, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: REGUEIRO A ET AL. INFECTIVE ENDOCARDITIS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT: COMPARISON OF BALLOON- VERSUS SELF-EXPANDABLE VALVES. CIRCULATION: CARDIOVASCULAR INTERVENTIONS. 2019;12:E007938. DOI: 10.1161/CIRCINTERVENTIONS.119.007938 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH DATE. MEDTRONIC PRODUCTS REFERENCED: COREVALVE TRANSCATHETER HEART VALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R TRANSCATHETER HEART VALVE (PMA# P130021, PRODUCT CODE NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 A NONRANDOMIZED, RETROSPECTIVE STUDY INTO THE INCIDENCE OF INFECTIVE ENDOCARDITIS (IE) FOLLOWING THE IMPLANTATION OF TRANSCATHETER AORTIC VALVE REPLACEMENTS (TAVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JUNE 2005 AND OCTOBER 2015. THE STUDY POPULATION INCLUDED 245 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 78 YEARS), 130 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE OR EVOLUT R TRANSCATHETER VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC COREVALVE AND EVOLUT R PATIENTS, 41 AND 27 DEATHS OCCURRED IN-HOSPITAL AND DURING FOLLOW-UP, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED ABOUT THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC COREVALVE AND EVOLUT R PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, SYSTEMIC EMBOLISM, MAJOR BLEEDING, PERMANENT PACEMAKER IMPLANT, ACUTE KIDNEY INJURY, INTRACARDIAC ABSCESS, PSEUDOANEURYSM, FISTULA, SEPTIC SHOCK, ENDOCARDITIS, SURGICAL VALVE EXPLANTATION, TRANSCATHETER VALVE-IN-VALVE REPLACEMENT, MODERATE-SEVERE PARAVALVULAR LEAK, AND MODERATE-SEVERE AORTIC REGURGITATION. IT WAS ALSO REPORTED THAT THE ORGANISMS CULTURED WERE ENTEROCOCCUS, STAPHYLOCOCCUS AUREUS, COAGULASE-NEGATIVE STAPHYLOCOCCI, AND VIRIDIANS STREPTOCOCCI. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155207 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death