BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20256956 · Received September 19, 2024

    Report

    Report Number
    2025587-2024-05236
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    March 13, 2023
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B5. 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

    CITATION: FUKUI M, SORAJJA P, CAVALCANTE JL, ET AL. DEFORMATION OF TRANSCATHETER HEART VALVE FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT: IMPLICATIONS FOR HEMODYNAMICS. JACC CARDIOVASC INTERV. 2023;16(5):515-526. DOI:10.1016/J.JCIN.2023.01.017 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: 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. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR STATED THAT THIS WAS AN OBSERVATIONAL STUDY, NOT AN OUTCOME STUDY, AND THEREFORE A LARGER STUDY WILL BE NEEDED TO SEE IF THERE WERE ADVERSE EVENTS. THE AUTHOR ALSO NOTED THAT TO THEIR KNOWLEDGE, REFERRING TO HIMSELF AND HIS CO-AUTHORS, NO ADVERSE EVENTS HAD OCCURRED. NO FURTHER SPECIFICS WERE GIVEN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING DEFORMATION OF TRANSCATHETER VALVES FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV TAVR). THE STUDY POPULATION CONSISTED OF 53 PATIENTS WHO UNDERWENT VIV TAVR IN A SURGICAL VALVE WITH A MEDTRONIC TRANSCATHETER VALVE BRAND (EVOLUT R, PRO, OR PRO+). DURING VIV TAVR, POST-IMPLANT BALLOON DILATION (N = 11) OR BIOPROSTHETIC VALVE FRACTURE (N = 13) WAS PERFORMED OR ATTEMPTED IN 24 PATIENTS. WITHIN 30 DAYS OF VIV TAVR, THE AUTHORS OBSERVED THE FOLLOWING PRODUCT PERFORMANCE ISSUES: VALVE DEFORMATION (FRAME UNDER-EXPANSION AND ASYMMETRIC LEAFLET EXPANSION), ELEVATED MEAN GRADIENT (RANGE OF 9 TO 19 MMHG), AND HYPOATTENUATED LEAFLET THICKENING WITH EVIDENCE OF REDUCED LEAFLET MOTION. ADVERSE EVENTS THAT OCCURRED DURING 30-DAY FOLLOW-UP INCLUDED: NEED FOR PACEMAKER IMPLANTATION AND THROMBUS FORMATION IN THE GAP BETWEEN THE TRANSCATHETER VALVE AND THE SURGICAL VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591611 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male