BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 16036509 · Received December 22, 2022

    Report

    Report Number
    2025587-2022-03693
    Event Type
    Death
    Date Received
    December 22, 2022
    Date of Event
    June 8, 2022
    Report Date
    March 31, 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: SCOTTI A.; ET AL. 10-YEAR IMPACT OF TRANSCATHETER AORTIC VALVE REPLACEMENT LEAFLET DESIGN (INTRA- VERSUS SUPRA-ANNULAR) IN MORTALITY AND HEMODYNAMIC PERFORMANCE. FRONT CARDIOVASC MED. 2022 JUN 8; 9:924958. DOI: 10.3389/FCVM.2022.924958. PMID: 35757343 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, 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. 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 · 0

    IN THE ARTICLE, ON TABLE 3, PATIENT #25 WAS THE 73-YEAR-OLD PATIENT AND PATIENT #26 WAS THE 85-YEAR-OLD PATIENT WHO DIED FROM HEART FAILURE RELATED TO COREVALVE SVD. THEIR WEIGHTS WERE PROVIDED AS 52 KILOGRAMS (KG) AND 85 KG, RESPECTIVELY. FOR THE PURPOSES OF THIS REPORT, THE PATIENTS' AGES AND WEIGHTS WERE AVERAGED (MEAN 79-YEARS-OLD AND MEAN WEIGHT OF 68.5 KG ROUNDED TO 69 KG). SELECT PATIENT AND PRODUCT INFORMATION COULD NOT BE INCLUDED IN THIS REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 COMPARING CLINICAL OUTCOMES IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLA CEMENT (TAVR) USING VALVES WITH INTRA-ANNULAR VERSUS SUPRA-ANNULAR LEAFLET DESIGNS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2007 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 604 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 81 YEARS. THE POPULATION WAS STRATIFIED INTO TWO COHORTS: INTRA-ANNULAR DESIGN (482 PATIENTS) AND SUPRA-ANNULAR DESIGN (122 PATIENTS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 99 PATIENTS WERE IMPLANTED WITH EITHER A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHESIS, AS PART OF THE SUPRA-ANNULAR LEAFLET COHORT. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE SUPRA-ANNULAR DESIGN PATIENT COHORT, OVERALL MORTALITY WAS 11% OVER A 12-YEAR FOLLOW-UP PERIOD. AMONG MEDTRONIC COREVALVE PATIENTS, ONE DEATH WAS NOTED TO BE VALVE-RELATED WITH THE PATIENT DEVELOPING SEVERE MIXED AORTIC STENOSIS/REGURGITATION FROM HEMODYNAMIC VALVE DETERIORATION (HVD) PRIOR TO EXPIRATION. THE CAUSE OF DEATH WAS NOT DESCRIBED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THAT DEATH. IN THE SUPRA-ANNULAR DESIGN GROUP, ADVERSE EVENTS INCLUDED: MODERATE PATIENT-PROSTHESIS MISMATCHES RESULTING IN ELEVATED TRANSVALVULAR GRADIENTS; HEMODYNAMIC VALVE DETERIORATION (HVD) LEADING TO SEVERE AORTIC STENOSIS/REGURGITATION, REQUIRING VALVE REPLACEMENT. 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT TWO OF THE VALVE-RELATED DEATHS IN THE ARTICLE WERE DUE TO HEART FAILURE AND WERE DIRECTLY RELATED TO COREVALVE STRUCTURAL VALVE DETERIORATION (SVD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918217 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Death