BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20418610 · Received October 10, 2024

    Report

    Report Number
    2025587-2024-05626
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 10, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ELLFORS E, DISMORR M, RÜCK A, SETTERGREN M, SARTIPY U, GLASER N. PREDICTED PROSTHESIS-PATIENT MISMATCH AND LONG-TERM CLINICAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: A SWEDEHEART STUDY. AM HEART J. 2024;276:70-82. DOI:10.1016/J.AHJ.2024.07.009 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED IN THE ARTICLE: COREVALVE (PRODUCT CODE NPT, PMA# P130021), 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 IMPACT OF PROSTHESIS-PATIENT MISMATCH (PPM) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 8,485 PATIENTS WHO UNDERWENT TAVR WITH EITHER A MEDTRONIC VALVE BRAND (COREVALVE/EVOLUT R/EVOLUT PRO/EVOLUT PRO+ = 2,853) OR A NON-MEDTRONIC VALVE BRAND (VARIOUS = 5,632). A TOTAL OF 2,990 PATIENTS DIED DURING FOLLOW-UP (MEAN OF 3 YEARS, MAXIMUM OF 14 YEARS). THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE FOLLOWING ADVERSE OUTCOMES WERE ALSO NOTED IN THE ARTICLE: PPM, NEED FOR PERMANENT PACEMAKER IMPLANTATION WITHIN 30 DAYS AFTER TAVR, PARAVALVULAR LEAK (MODERATE OR SEVERE), ELEVATED OR HIGH MEAN GRADIENTS (<(><<)> 20 MMHG OR = 20 MMHG), AORTIC VALVE REINTERVENTION (SURGICAL OPERATION OR VALVE-IN-VALVE TAVR), AND HOSPITALIZATION FOR HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934254 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 Male Life Threatening| R| H