BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20354382 · Received October 2, 2024

    Report

    Report Number
    2025587-2024-05477
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    June 27, 2024
    Report Date
    October 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: OKADA A, FUKUI M, ZAID S, ET AL. IN VIVO COMPUTED TOMOGRAPHY SIZING FOR REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT IN EVOLUT VALVES: IMPACT ON SIZING, FEASIBILITY, AND PROSTHESIS-PATIENT MISMATCH. CIRC CARDIOVASC INTERV. 2024;17(8):E013903. DOI:10.1161/ CIRCINTERVENTIONS.123.013903 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT PRO+ (PRODUCT CODE NPT, PMA# P130021). 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE USE OF IN VIVO COMPUTED TOMOGRAPHY SIZING TO DETERMINE THE FEASIBILITY OF REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 290 PATIENTS WHO HAD UNDERGONE TAVR WITH A MEDTRONIC VALVE BRAND (EVOLUT R, PRO, OR PRO+). TO ASSESS THE FEASIBILITY OF REDO-TAVR USING A NON-MEDTRONIC VALVE (SAPIEN 3), THE AUTHORS ANALYZED EACHPATIENT¿S 30-DAY POST-TAVR COMPUTED TOMOGRAPHY (CT) IMAGES. DURING THEIR CT IMAGE REVIEW, THE AUTHORS OBSERVED INSTANCES WHERE THE EVOLUT VALVE FRAME WAS UNDER-EXPANDED. NO ADVERSE EFFECTS OR INTERVENTIONS (REDO-TAVR OR SOME OTHER ACTION) WERE RECOUNTED IN THE ARTICLE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686530 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 Female