BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12308087 · Received August 11, 2021

    Report

    Report Number
    2025587-2021-02525
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    January 4, 2021
    Report Date
    August 11, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CARRABBA N, ET AL. LONG-TERM DURABILITY OF TRANSCATHETER AORTIC VALVE IMPLANTATION WITH SELF-EXPANDABLE VALVE SYSTEM (FROM A REAL-WORLD REGISTRY). AM J CARDIOL. 2021 MAR 15;143:104-110. DOI: 10.1016/J.AMJCARD.2020.12.032. EPUB 2021 JAN 4. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (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 FROM A LITERATURE ARTICLE REGARDING THE LONG-TERM PATIENT OUTCOMES AND PROSTHESIS PERFORMANCE OF THE COREVALVE AND EVOLUT R SELF-EXPANDABLE TRANSCATHETER VALVES. ALL DATA WAS COLLECTED FROM A SINGLE CENTER REGISTRY BETWEEN JANUARY 2009 AND JULY 2017. ALL 182 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 82.9 YEARS) UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH THE MEDTRONIC COREVALVE OR EVOLUT R. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 111 DEATHS OCCURRED DURING AN AVERAGE FOLLOW-UP OF 2.8 YEARS. MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THREE OF THESE DEATHS. THE FIRST DEATH, PATIENT DIED OF A FATAL STROKE. THE SECOND DEATH, CLASSIFIED AS A VALVE-RELATED DEATH, PATIENT WAS HOSPITALIZED FOR RECURRENT HEART FAILURE 65 DAYS AFTER TAVI (TREATED WITH A 26 MM COREVALVE) AND SUBSEQUENTLY DIED IN-HOSPITAL 30 DAYS LATER. THE THIRD DEATH, PATIENT WAS DECOMPENSATED AND HOSPITALIZED 126 DAYS AFTER TAVI (TREATED WITH A 31 MM COREVALVE), SHOWING A PROGRESSION FROM MODERATE TO SEVERE MITRAL REGURGITATION DUE TO INTERFERENCE FROM THE COREVALVE WITH THE ANTERIOR MITRAL LEAFLET AND SUBSEQUENTLY DIED ONE YEAR AFTER REFUSING SURGERY. NO CORRELATION WAS MADE BETWEEN MEDTRONIC PRODUCT AND THE OTHER DEATHS. AMONG ALL PATIENTS, NON-DEATH ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION FOR ADVANCED ATRIOVENTRICULAR BLOCK; CEREBRO VASCULAR/NEUROLOGICAL EVENTS; LIFE-THREATENING BLEEDING; VALVE MIGRATION CAUSING DECOMPENSATION AND AORTIC PSEUDOANEURYSM NECESSITATING SURGICAL AORTIC VALVE REPLACEMENT; MILD TO MODERATE PARAVALVULAR LEAK; AND STRUCTURAL VALVE DETERIORATION (STENOSIS, MEAN TRANSAORTIC GRADIENT RANGING FROM 20 TO 40 MM HG, MODERATE AORTIC REGURGITATION). DURING FOLLOW-UP, REHOSPITALIZATION WAS NECESSARY FOR R ECURRENT HEART FAILURE, PERMANENT PACEMAKER IMPLANTATION, OR CARDIAC RESYNCHRONIZATION THERAPY FOR SYMPTOMATIC HEARTFAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205350 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death