BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20451002 · Received October 15, 2024

    Report

    Report Number
    2025587-2024-05718
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    July 8, 2024
    Report Date
    October 15, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MICHEL POMPEU SA, ET AL. SUPRA-ANNULAR VERSUS INTRA-ANNULAR SELF-EXPANDING VALVES IN SMALL AORTIC ANNULUS: A PROPENSITY SC ORE-MATCHED STUDY. STRUCTURAL HEART. 100334. PUBLISHED ONLINE JULY 8, 2024. HTTPS://DOI.ORG/10.1016/J.SHJ.2024.100334. 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), EVOLUT PRO+ (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT FX (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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN SMALL AORTIC ANNULI WITH SUPRA-ANNULAR VALVES (SAVS) VERSUS INTRA-ANNULAR VALVES (IAVS). THE STUDY POPULATION CONSISTED OF 583 PATIENTS WHO UNDERWENT TAVR WITH EITHER A MEDTRONIC SAV (COREVALVE/EVOLUT R/PRO/PRO+/FX = 477) OR A NON-MEDTRONIC IAV (PORTICO/NAVITOR = 106). IN THE MEDTRONIC SAV GROUP, THE AUTHORS OBSERVED EARLY AND LATE DEATHS DURING TWO YEARS OF FOLLOW-UP. HOWEVER, THE CIRCUMSTANCES OF THE DEATHS WERE NOT DESCRIBED BY THE AUTHORS, NOR WAS ANY EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE FOLLOWING ADVERSE OUTCOMES WERE CLEARLY ITEMIZED AS HAVING OCCURRED IN THE MEDTRONIC SAV GROUP: PERMANENT PACEMAKER IMPLANTATION, PARAVALVULAR LEAK (MODERATE TO SEVERE), ELEVATED OR HIGH MEAN GRADIENTS (20 MMHG OR > 20 MMHG), STROKE, AND PROSTHESIS-PATIENT MISMATCH. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295050 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 Female Required Intervention| L