BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14489572 · Received May 24, 2022

    Report

    Report Number
    2025587-2022-01460
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CLERFOND ET AL. HOW TO USE THE AORTIC VALVE CALCIUM SCORE TO IMPROVE THE RESULTS OF TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A SELF-EXPANDING PROSTHESIS. ARCH CARDIOVASC DIS. 2022 APR 21;S1875-2136(22)00047-X. DOI: 10.1016/J.ACVD.2022.03.001. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R AND EVOLUT PRO. 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. 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

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AORTIC VALVE CALCIUM SCORE FOR TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH SELF-EXPANDING PROSTHESES. ALL DATA WERE COLLECTED FROM A SINGLE FRENCH CENTER BETWEEN JANUARY 2018 AND MARCH 2019. THE STUDY POPULATION INCLUDED 168 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82.1 YEARS. ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R (N=79) OR EVOLUT PRO (N=89) BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, TWO PATIENTS DIED DURING THE HOSPITAL PHASE. ONE POLY PATHOLOGICAL PATIENT DIED AS A RESULT OF SEVERE LOW-OUTPUT LEFT VENTRICULAR DYSFUNCTION. A SECOND PATIENT DIED AS A RESULT OF FIBRINOLYZED STROKE COMPLICATED BY SUBARACHNOID HEMORRHAGE AND PERICARDIAL EFFUSION. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), MODERATE AORTIC REGURGITATION (AR), CONDUCTION DISTURBANCE REQUIRING PERMANENT PACEMAKER, TAMPONADE, STROKE, VASCULAR COMPLICATION, BLEEDING COMPLICATION, AND CONVERSION TO SURGERY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221496 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 Female Hospitalization| L| R