BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11930254 · Received June 3, 2021

    Report

    Report Number
    2025587-2021-01766
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    November 3, 2020
    Report Date
    June 3, 2021
    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: VERA VERA S, ET AL. SELF-EXPANDABLE TRANSCATHETER HEART VALVES FOR AORTIC STENOSIS. SHORT-TERM OUTCOME AND MATCHED HEMODYNAMIC PERFORMANCE. REV ESP CARDIOL (ENGL ED). 2020 NOV 3;S1885-5857(20)30422-9. DOI: 10.1016/J.REC.2020.09.014. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO (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 A COMPARISON OF THE PATIENT OUTCOMES AND HEMODYNAMIC PERFORMANCE FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE EVOLUT R/EVOLUT PRO, ACURATE NEO, ALLEGRA, AND PORTICO VALVES. ALL DATAWAS RETROSPECTIVELY COLLECTED FROM FOUR CENTERS BETWEEN JANUARY 2017 AND JANUARY 2019. OF THE 514 PATIENTS INCLUDED IN THE STUDY POPULATION, 217 WERE IMPLANTED WITH MEDTRONIC EVOLUT R OR EVOLUT PRO TRANSCATHETER VALVES (PREDOMINANTLY MALE, MEAN AGE 81.4 YEARS). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, 3 PROCEDURAL AND 7 IN-HOSPITAL DEATHS OCCURRED, RESPECTIVELY. NO FURTHER DETAILS WERE D ISCLOSED. CONSIDERING THE TIMING OF WHEN THESE DEATHS OCCURRED, MEDTRONIC PRODUCT MAY HAVE BEEN A CONTRIBUTORY FACTOR. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, THE PROCEDURAL, IN-HOSPITAL, AND THIRTY-DAY OUTCOMES INCLUDED: MORE THAN ONE VALVE REQUIRED; VALVE EMBOLIZATION; ANNULUS RUPTURE; CORONARY ARTERY OCCLUSION; PERMANENT PACEMAKER IMPLANTATION; NEW ONSET ATRIAL FIBRILLATION; CEREBROVASCULAR EVENTS; MAJOR VASCULAR COMPLICATIONS; LIFE-THREATENING OR MAJOR BLEEDING; MILD TO SEVERE PERI-PROSTHETIC (PARAVALVULAR) AORTIC REGURGITATION; AND MILD INTRA-PROSTHETIC (CENTRAL) AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825832 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death