BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 16809880 · Received April 25, 2023

    Report

    Report Number
    2025587-2023-01675
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    March 10, 2023
    Report Date
    April 25, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PYKÄRI, J., VASANKARI, T., YLITALO, A. ET AL. IMPACT OF INTRAPROCEDURAL PRESSURE CHANGES ON HEMODYNAMIC OUTCOME DURING SELF-EXPANDING TAVR. CARDIOL THER (2023). HTTPS://DOI.ORG/10.1007/S40119-023-00307-8 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). EARLIEST APP ROVED 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE IMPACT OF INTRAPROCEDURAL PRESSURE CHANGES ON HEMODYNAMIC OUTCOME DURING SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THIRTY-EIGHT PATIENTS WHO UNDERWENT TAVR WITH MEDTRONIC EVOLUT R OR EVOLUT PRO SELF-EXPANDABLE VALVES WERE INCLUDED IN THE STUDY. THE AUTHORS WROTE, ¿PATIENTS WERE CLASSIFIED INTO TWO GROUPS, NAMELY, THOSE WHO EXPERIENCED A PRESSURE DROP (DECREASE IN SYSTOLIC PRESSURE OF 30 MMHG, N = 23) AND THOSE WHO DID NOT (NON-PRESSURE DROP, N = 15) ACCORDING TO THE AORTIC PRESSURE CHANGES AFTER VALVE PROSTHESIS ACHIEVED THE ANNULAR CONTACT. ONLY PRESSURE CHANGES OCCURRING IMMEDIATELY AFTER ANNULAR CONTACT WERE ANALYZED.¿ PROCEDURAL AND 30-DAY OUTCOMES WERE DESCRIBED AS FOLLOWS: AORTIC SYSTOLIC PRESSURE DECREASE AFTER ANNULAR CONTACT BY THE SELF-EXPANDING VALVE FRAME, MODERATE-TO-SEVERE PARAVALVULAR LEAK (PVL) SEEN ON PROCEDURAL AORTOGRAPHY (TREATED WITH A BALLOON POST-DILATION), MILD OR MODERATE PVL AT 30-DAY FOLLOW-UP, LOW EJECTION FRACTION (<(><<)>50%), AND PERMANENT PACEMAKER IMPLANTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413172 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 Required Intervention