BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21775827 · Received April 4, 2025

    Report

    Report Number
    2025587-2025-02368
    Event Type
    Death
    Date Received
    April 4, 2025
    Date of Event
    June 25, 2024
    Report Date
    April 4, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BASHIR H, SCHMIDT CW, ANSAH K, ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL AORTIC ANNULUS: AN OBSERVATIONAL STUDY. STRUCT HEART. 2024;9(2):100338. PUBLISHED 2024 JUN 25. DOI:10.1016/J.SHJ.2024.100338 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC VALVE BRANDS USED IN THE STUDY: EVOLUT R (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 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH SMALL AORTIC ANNULI (SAA). THE STUDY POPULATION CONSISTED OF 258 PATIENTS WITH SAA WHO UNDERWENT TAVR WITH EITHER A NON-MEDTRONIC BALLOON-EXPANDABLE VALVE (BEV = 90) OR A MEDTRONIC SELF-EXPANDING VALVE (SEV = 168). IN THE SEV GROUP, THE FOLLOWING ADVERSE OUTCOMES OCCURRED: AORTIC REGURGITATION (MODERATE TO SEVERE), PATIENT-PROSTHESIS MISMATCH (PPM), STROKE/DISABLING STROKE, MYOCARDIAL INFARCTION, REHOSPITALIZATION FOR HEART FAILURE, AND REINTERVENTION REQUIRED (SURGICAL EXPLANT OR VALVE-IN-VALVE REPLACEMENT) DUE TO VALVE MALPOSITION OR STRUCTURAL VALVE DETERIORATION. ADDITIONALLY, AMONG SEV PATIENTS, THE AUTHORS OBSERVED 4 IN-HOSPITAL DEATHS AND AN ADDITIONAL 38 DEATHS WITHIN THREE YEARS OF TAVR. WHILE THE AUTHORS FOUND THAT THE OCCURRENCE OF PPM HAD ¿NO DISCERNIBLE EFFECT¿ ON THE OUTCOMES OF DEATH, STROKE, AND MYOCARDIAL INFARCTION, A POTENTIAL DEVICE RELATIONSHIP TO THESE OUTCOMES CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744420 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 Death