BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12713442 · Received October 28, 2021

    Report

    Report Number
    2025587-2021-03284
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    February 27, 2021
    Report Date
    October 28, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MEGURO K., ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH A SMALL ANNULUS FROM THE (B)(6) NATIONWIDE REGISTRY (J-TVT). CIRC J. (B)(6) 2021; 85(7):967-976. DOI: 10.1253/CIRCJ.CJ-20-1084. EPUB (B)(6) 2021. PMID: 33642425. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R (PMA# (B)(4)). 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE SHORT-TERM OUTCOMES OF PATIENTS WITH SMALL AORTIC ANNULUS SIZES WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND THE DIFFERENCES IN OUTCOMES OF INTRA-ANNULAR VERSUS SUPRA-ANNULAR TRANSCATHETER HEART VALVES. ALL DATA WERE COLLECTED FROM A JAPANESE NATIONAL CLINICAL REGISTRY (J-TVT) BETWEEN AUGUST 2013 AND DECEMBER 2017. THE STUDY POPULATION INCLUDED 5870 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 85 YEARS), 600 OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE AND 1166 OF WHOM WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 44 PATIENTS DIED WITHIN 30 DAYS POST-TAVR, HOWEVER 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: ANNULUS RUPTURE DURING TAVR, CORONARY OBSTRUCTION, NEED TO CONVERT TO OPEN-HEART SURGERY, SEVERE PATIENT-PROSTHESIS MISMATCH (PPM),NEED FOR NEW PACEMAKER IMPLANTATION, STROKES AND MODERATE-SEVERE PARAVALVULAR LEAKS (PVLS). BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    1610526 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R