BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10925707 · Received December 1, 2020

    Report

    Report Number
    2025587-2020-03643
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    October 1, 2020
    Report Date
    March 22, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    CITATION: CHOI C., ET AL. COMPARISON OF OUTCOMES OF REDO-AORTIC VALVE REPLACEMENT: TRANSCATHETER VERSUS SURGICAL APPROACH. J AM COLL CARDIOL, 2020 OCT; 76(17 SUPPLEMENT S):B59. DOI: 10.1016/J.JACC.2020.09.149. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE: LWR), EVOLUT-R (PMA# P130021, PRODUCT CODE: NPT). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE COMPARING THE OUTCOMES OF RE-DO SURGICAL VERSUS VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (SAVR VERSUS VIV TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2009-2019. THE STUDY POPULATION INCLUDED 176 PATIENTS (SAVR GROUP MEAN AGE 58 YEARS AND VIV TAVR GROUP MEAN AGE 67 YEARS), AN UNDETERMINED NUMBER OF WHOM WERE IMPLANTED WITH MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESES AND MEDTRONIC EVOLUT-R BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC FREESTYLE PATIENTS, INPATIENT MORTALITY WAS 16% VERSUS 2.78% AMONG ALL MEDTRONIC EVOLUT-R PATIENTS. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC FREESTYLE PATIENTS, ADVERSE EVENTS INCLUDED: ACUTE KIDNEY INJURY, RE-HOSPITALIZATIONS AND STROKES. AMONG ALL MEDTRONIC EVOLUT-R PATIENTS, ADVERSE EVENTS INCLUDED: NEW-ONSET LEFT BUNDLE BRANCH BLOCK (LBBB), RE-HOSPITALIZATIONS AND STROKES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395111 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization