BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20374019 · Received October 4, 2024

    Report

    Report Number
    2025587-2024-05517
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    June 10, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SATHAN ANTHAN J, NIGADE A, MEIER D, ET AL. HYDRODYNAMIC ASSESSMENT OF EXPLANTED DEGENERATED TRANSCATHETER AORTIC VALVES: NOVEL INSIGHTS INTO NONCALCIFIC AND CALCIFIC MECHANISMS. JACC CARDIOVASC INTERV. 2024;17(11):1340-1351. DOI:10.1016/J.JCIN.2024.04.011 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), AND 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: SECTION B5 - ADDED SECOND PARAGRAPH. SEE ATTACHED EXCEL FILE FOR THE RESPECTIVE DEVICE SERIAL NUMBER (IF KNOWN) AND INITIAL MDR NUMBER FOR THE 6 EXPLANTED MEDTRONIC VALVES THAT CAME FROM MEDTRONIC'S INTERNAL STORAGE BANK. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE NON-CALCIFIC AND CALCIFIC MECHANISMS OF DEGENERATION IN EXPLANTED TRANSCATHETER AORTIC VALVES. OF THE 14 EXPLANTED VALVES EVALUATED BY THE AUTHORS, 10 WERE MEDTRONIC BRANDS (COREVALVE = 3, EVOLUT R = 3, EVOLUT PRO = 2, AND EVOLUT PRO+ = 2). THE AUTHORS ALSO NOTED THAT ONE OF THE EXPLANTED EVOLUT R VALVES HAD BEEN IMPLANTED VALVE-IN-VALVE IN AN EVOLUT R VALVE. AMONG THE MEDTRONIC VALVES, REASONS FOR EXPLANTATION CONSISTED OF AORTIC STENOSIS, CENTRAL AORTIC REGURGITATION, PARAVALVULAR LEAK, ENDOCARDITIS, PATIENT-PROSTHESIS MISMATCH, VALVE MIGRATION, AND PANNUS FORMATION. PRIOR TO EXPLANTATION, MEAN GRADIENTS BETWEEN 15 AND 44 MM HG WERE RECORDED FOR THE MEDTRONIC VALVES. FIVE OF THE EXPLANTED MEDTRONIC VALVES HAD LEAFLET CALCIFICATION, WHILE ALL THE EXPLANTED VALVES HAD RESTRICTED OR ASYNCHRONOUS LEAFLET MOTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE NON-CALCIFIC AND CALCIFIC MECHANISMS OF DEGENERATION IN EXPLANTED TRANSCATHETER AORTIC VALVES. OF THE 14 EXPLANTED VALVES EVALUATED BY THE AUTHORS, 10 WERE MEDTRONIC BRANDS (COREVALVE = 3, EVOLUT R = 3, EVOLUT PRO = 2, AND EVOLUT PRO+ = 2). THE AUTHORS ALSO NOTED THAT ONE OF THE EXPLANTED EVOLUT R VALVES HAD BEEN IMPLANTED VALVE-IN-VALVE IN AN EVOLUT R VALVE. AMONG THE MEDTRONIC VALVES, REASONS FOR EXPLANTATION CONSISTED OF AORTIC STENOSIS, CENTRAL AORTIC REGURGITATION, PARAVALVULAR LEAK, ENDOCARDITIS, PATIENT-PROSTHESIS MISMATCH, VALVE MIGRATION, AND PANNUS FORMATION. PRIOR TO EXPLANTATION, MEAN GRADIENTS BETWEEN 15 AND 44 MM HG WERE RECORDED FOR THE MEDTRONIC VALVES. FIVE OF THE EXPLANTED MEDTRONIC VALVES HAD LEAFLET CALCIFICATION, WHILE ALL THE EXPLANTED VALVES HAD RESTRICTED OR ASYNCHRONOUS LEAFLET MOTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT 6 OF THE 10 EXPLANTED MEDTRONIC VALVES HAD COME DIRECTLY FROM MEDTRONIC'S INTERNAL BANK OF EXPLANTED VALVES AND ALL 6 WERE PREVIOUSLY CAPTURED IN INDIVIDUAL FILES IN MEDTRONIC'S COMPLAINT HANDLING DATABASE. THE REMAINING 4 EXPLANTED MEDTRONIC VALVES HAD COME FROM AN EXTERNAL CANADIAN TISSUE BANK. MEDTRONIC DOES NOT HAVE NOR CAN OBTAIN SERIAL NUMBERS FOR THESE 4 VALVES AS THE EXTERNAL TISSUE BANK DOES NOT COLLECT OR DISTRIBUTE SERIAL NUMBERS. CONSEQUENTLY, IT CANNOT BE CONFIRMED WHETHER THESE 4 EXPLANTED VALVES WERE PREVIOUSLY CAPTURED IN MEDTRONIC'S COMPLAINT HANDLING DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704428 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R