BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 16668502 · Received April 3, 2023

    Report

    Report Number
    2025587-2023-01318
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    September 1, 2022
    Report Date
    April 3, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PELLEGRINI C, ET AL. PERMANENT PACEMAKER IMPLANTATION AND LEFT BUNDLE BRANCH BLOCK WITH SELF-EXPANDING VALVES ¿ A SCOPE 2 SUBANALYSIS. EUROINTERVENTION. 2023 FEB 6;18(13):E1077-E1087. DOI: 10.4244/EIJ-D-22-00558. PUBLISHED ONLINE AHEAD OF PRINT SEPTEMBER 2022. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT: SEPTEMBER 01, 2022 (MONTH AND YEAR VALID). 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 INCIDENCE AND IMPACT OF NEW LEFT BUNDLE BRANCH BLOCK (LBBB) AND PERMANENT PACEMAKER IMPLANTATION (PPI) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH SELF-EXPANDING VALVES. MEDTRONIC (EVOLUT R = 398) AND NON-MEDTRONIC (BOSTON SCIENTIFIC ACURATE NEO = 398) SELF-EXPANDING VALVES WERE USED IN THE STUDY. THE AUTHORS OBSERVED AN UNSPECIFIED NUMBER OF ALL-CAUSE DEATHS WITHIN ONE YEAR OF TAVR. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OVERALL, 107 PATIENTS REQUIRED PPI AFTER TAVR. MOST OF THE PACEMAKERS WERE IMPLANTED WITHIN THREE DAYS OF TAVR (72.9%), WHILE ONLY THREE PATIENTS REQUIRED PPI BETWEEN 30 DAYS AND ONE YEAR FOLLOWING TAVR. THE INDICATIONS FOR PACEMAKER IMPLANTATION INCLUDED: ATRIOVENTRICULAR BLOCK I, II, OR III; LBBB; AND OTHER/UNKNOWN CONDUCTION ABNORMALITIES. OTHER ADVERSE EVENTS THAT OCCURRED WERE DESCRIBED AS FOLLOWS: NEW-ONSET LBBB (WITHOUT THE NEED FOR PPI), WORSENED NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS (HEART FAILURE SYMPTOMS), AND REDUCED LEFT VENTRICULAR FUNCTION/EJECTION FRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529511 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention