BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20843357 · Received December 4, 2024

    Report

    Report Number
    2025587-2024-06986
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    May 22, 2024
    Report Date
    December 4, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALABDALJABAR MS, ELHADI M, GULATI R, ET AL. THIRTY-DAY HIGH-GRADE AORTIC VALVE BLOCK POST-TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS DISCHARGED ON HEART RHYTHM MONITOR. STRUCT HEART. 2024;8(4):100317. PUBLISHED 2024 MAY 22. DOI:10.1016/J.SHJ.2024.10031. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC VALVE BRANDS USED IN THE STUDY: 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE INCIDENCE OF HIGH-GRADE ATRIOVENTRICULAR BLOCK (HAVB) IN PATIENTS ON AMBULATORY CARDIAC MONITORING AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 528 PATIENTS WHO UNDERWENT TAVR WITH EITHER A NON-MEDTRONIC VALVE BRAND (N = 491) OR A MEDTRONIC VALVE BRAND (N = 37). AMONG ALL PATIENTS, THE FOLLOWING ADVERSE OUTCOMES OCCURRED AFTER TAVR: PERMANENT PACEMAKER IMPLANTATION FOR HAVB OR ANOTHER INDICATION. ADDITIONAL POST-TAVR ELECTROCARDIOGRAM CHANGES RECOUNTED IN THE ARTICLE: FIRST-DEGREE HEART BLOCK, LEFT AND RIGHT BUNDLE BRANCH BLOCK, AND LEFT ANTERIOR FASCICULAR BLOCK. DURING A MEDIAN FOLLOW-UP OF TWO YEARS, THE AUTHORS RECORDED A MORTALITY RATE OF 15.0%. THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942301 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention