BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 19159629 · Received April 22, 2024

    Report

    Report Number
    2025587-2024-02432
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    January 8, 2024
    Report Date
    April 22, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TABATA H, ISHIZU K, MURAKAMI N, HAYASHI M, SHIRAI S, ANDO K. BAILOUT STENTING FOR DELAYED CORONARY OBSTRUCTION AFTER SELF-EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTATION. CARDIOVASC INTERV THER. 2024;39(2):210-211. DOI:10.1007/S12928-023-00978-Z 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. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO UNDERWENT SUCCESSFUL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A 26 MM MEDTRONIC EVOLUT PRO VALVE. AORTOGRAPHY AFTER VALVE IMPLANT SHOWED A HIGH IMPLANT POSITION WITH INTACT CORONARY FLOW. HOWEVER, ONE HOUR AFTER ARRIVING IN THE INTENSIVE CARE UNIT, THE PATIENT WENT INTO SHOCK WITH LOSS OF CONSCIOUSNESS. VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION WAS INITIATED, AND THEN EMERGENT CORONARY ANGIOGRAPHY (CAG) SHOWED SUB-OCCLUSION OF LEFT CORONARY ARTERY (LCA) AND SEQUESTRATION OF THE SINUS OF VALSALVA. CONSEQUENTLY, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED, AND TWO CORONARY STENTS WERE PLACED. AFTERWARD, FINAL CAG SHOWED GOOD LCA FLOW. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED FROM THE HOSPITAL THIRTY-ONE DAYS LATER. THE AUTHORS WROTE THAT POST-PROCEDURAL COMPUTED TOMOGRAPHY ANALYSIS CONFIRMED THAT ONE OF THE EVOLUT PRO COMMISSURES WAS POSITIONED IN FRONT OF THE LCA. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO THE EVOLUT PRO VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823485 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R