BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 17475792 · Received August 7, 2023

    Report

    Report Number
    2025587-2023-03238
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    September 24, 2022
    Report Date
    August 7, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PINNACCHIO G, RUSCIO E, ROCCO E, ET AL. SHORT-TERM ATRIOVENTRICULAR DYSFUNCTION RECOVERY AFTER POST-TAVI PACEMAKER IMPLANT ATION. J CARDIOVASC DEV DIS. 2022;9(10):324. PUBLISHED 2022 SEP 24. DOI:10.3390/JCDD9100324. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC TRANSCATHETER VALVE PRODUCTS THAT MAY HAVE BEEN INVOLVED IN THE LITERATURE GROUP STUDY: 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). 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 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE PREVALENCE AND PREDICTORS OF EARLY CONDUCTION ABNORMALITIES RECOVERY IN PATIENTS WHO UNDERWENT PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). A TOTAL OF 50 PATIENTS WERE INCLUDED IN THE STUDY POPULATION. BALLOON-EXPANDABLE (6%) AND SELF-EXPANDABLE (94%) VALVE TYPES WERE USED IN THE STUDY, BUT THE BRAND NAMES AND MANUFACTURERS OF THE VALVES WERE NOT DISCLOSED. SINCE MEDTRONIC IS THE MANUFACTURER OF A MULTI-GENERATIONAL SELF-EXPANDABLE TAVI PLATFORM, IT IS LIKELY THAT SOME OF THE PATIENTS IN THE STUDY RECEIVED A MEDTRONIC VALVE. ALL 50 PATIENTS REQUIRED PERMANENT PACEMAKER IMPLANTATION DURING THE SAME HOSPITALIZATION FOR TAVI (70% WITHIN SIX DAYS POST-PROCEDURE). INDICATIONS FOR PACEMAKER IMPLANTATIONWERE AS FOLLOWS: PERSISTENT THIRD-DEGREE ATRIOVENTRICULAR BLOCK (44%), PERSISTENT HIGH-DEGREE ATRIOVENTRICULAR BLOCK (20%), ATRIAL FIBRILLATION WITH SLOW VENTRICULAR CONDUCTION (16%), INTERMITTENT HIGH-DEGREE ATRIOVENTRICULAR BLOCK WITH NEW LEFT BUNDLE BRANCH BLOCK (12%), AND INTERMITTENT HIGH-DEGREE ATRIOVENTRICULAR BLOCK WITHOUT NEW LEFT BUNDLE BRANCH BLOCK (8%). OTHER COMPLICATIONS OBSERVED BY THE AUTHORS: SEVERE PARAVALVULAR LEAK (2 CASES). NO ADDITIONAL ADVERSE EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325623 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention