BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10532362 · Received September 14, 2020

    Report

    Report Number
    2025587-2020-02826
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    May 1, 2020
    Report Date
    September 14, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RAHEJA H., ET AL. COMPARISON OF BALLOON EXPANDABLE VS SELF- EXPANDABLE VALVE FOR TRANS-CATHETER AORTIC VALVE REPLACEMENT: A META-ANALYSIS. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, MAY 2020; 95:S216-S217, IV-69. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE [MEDTRONIC PRODUCTS REFERENCED: COREVALVE AND 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. 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 THE CLINICAL AND SAFETY OUTCOMES OF SELF-EXPANDABLE TRANSCATHETER AORTIC VALVES (SEV) VERSUS BALLOON-EXPANDABLE TRANSCATHETER AORTIC VALVES (BEV). ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF 16 STUDIES. THE STUDY POPULATION INCLUDED 8671 PATIENTS, WITH AN UNDISCLOSED NUMBER OF WHOM IMPLANTED WITH MEDTRONIC COREVALVE AND EVOLUT R BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, IT WAS NOTED THAT THE SEV GROUP HAD A HIGHER OVERALL 30-DAY MORTALITY RATE VERSUS THE BEV GROUP (ODDS RATIO 2.73 VERSUS 1.76) AND NO DIFFERENCE IN 30-DAY CARDIAC MORTALITY (ODDS RATIO 1.25). NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR PERMANENT PACEMAKER IMPLANTATION, SEVERE POST-PROCEDURE PARAVALVULAR LEAKS, MO DERATE-SEVERE POST-PROCEDURE TRANS-VALVULAR AORTIC REGURGITATION, MAJOR VASCULAR EVENTS, LIFE-THREATENING BLEEDING, MYOCARDIAL INFARCTIONS AND STROKES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL PATIENTS, MALFUNCTIONS INCLUDED: UNCHARACTERIZED DEVICE FAILURES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE MALFUNCTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995371 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other