BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX VALVE

    MDR report key: 20859440 · Received December 5, 2024

    Report

    Report Number
    2025587-2024-07073
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    October 9, 2024
    Report Date
    December 5, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHIANG ET AL. TRANSCAVAL IMPELLA-ASSISTED CHIP-PCI AND TRANSCAVAL TAVR WITH IMPELLA REMOVAL IN FRESHLY IMPLANTED TAVR. JACC: CARDIOVASCULAR INTERVENTIONS VOLUME: 17, ISSUE: 21, 2565-2566 2024. 10.1016/J.JCIN.2024.08.014. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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

    LITERATURE WAS REVIEWED REGARDING A 67-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF DIABETES MELLITUS, HYPERTENSION, SEVERE PERIPHERAL VASCULAR DISEASE, AND CONGESTIVE HEART FAILURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A PLANNED TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE A MEDTRONIC 26-MM EVOLUT FX BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. FOLLOWING VALVE PLACEMENT, A NON-MEDTRONIC TEMPORARY HEART PUMP WAS PLACED THROUGH THE NEWLY IMPLANTED VALVE. NEXT, A DRUG-ELUTING STENT WAS IMPLANTED IN THE MID¿LEFT ANTERIOR DESCENDING ARTERY VIA INTRAVASCULAR ULTRASOUND-GUIDED PCI. THE TEMPORARY HEART PUMP WAS CAREFULLY WITHDRAWN THROUGH THE VALVE AND OUT THE PATIENT WITHOUT COMPLICATION. AT ONE DAY POST-PROCEDURE THE PATIENT DEVELOPED COMPLETE HEART BLOCK WHICH REQUIRED IMPLANT OF A PERMANENT PACEMAKER. AT FOUR DAYS POST-INDEX PROCEDURE THE PATIENT WAS DISCHARGED HOME. AT A 9-MONTH FOLLOW-UP, THE PATIENT WAS FOUND TO BE IN STABLE CONDITION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542697 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-26

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R| L