BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23619083 · Received November 21, 2025

    Report

    Report Number
    9617601-2025-02916
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    June 24, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    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: SAIGAN M, MIYASAKA M, TAZAWA D, ET AL. FEASIBILITY OF GUIDING CATHETER EXCHANGE USING EXTENSION WIRE IN PERCUTANEOUS CORONARY INTERVENTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. CARDIOVASC INTERV THER. 2025;40(4):820-826. DOI:10.1007/S12928-025-01159-W EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. EARLIEST APPROVED EVOLUT 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 THE 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

    ADDITIONAL INFORMATION: B5 (SECOND PARAGRAPH). 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 FEASIBILITY OF GUIDING CATHETER EXCHANGE DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 11 PATIENTS WHO PREVIOUSLY UNDERWENT TAVR WITH EITHER A MEDTRONIC EVOLUT VALVE (N = 3) OR A NON-MEDTRONIC VALVE BRAND (N = 8). CLINICAL EVENTS THAT PROMPTED PCI ENCOMPASSED: STABLE CORONARY ARTERY DISEASE (N = 8), UNSTABLE ANGINA (N = 2), AND ACUTE MYOCARDIAL INFARCTION (N = 1). PCI WAS SUCCESSFULLY COMPLETED IN 10 PATIENTS, WHILE THE REMAINING PATIENT REQUIRED CONVERSION TO CORONARY ARTERY BYPASS GRAFTING WITH THE SUPPORT OF A MECHANICALCIRCULATORY DEVICE.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE FEASIBILITY OF GUIDING CATHETER EXCHANGE DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 11 PATIENTS WHO PREVIOUSLY UNDERWENT TAVR WITH EITHER A MEDTRONIC EVOLUT VALVE (N = 3) OR A NON-MEDTRONIC VALVE BRAND (N = 8). CLINICAL EVENTS THAT PROMPTED PCI ENCOMPASSED: STABLE CORONARY ARTERY DISEASE (N = 8), UNSTABLE ANGINA (N = 2), AND ACUTE MYOCARDIAL INFARCTION (N = 1). PCI WAS SUCCESSFULLY COMPLETED IN 10 PATIENTS, WHILE THE REMAINING PATIENT REQUIRED CONVERSION TO CORONARY ARTERY BYPASS GRAFTING WITH THE SUPPORT OF A MECHANICAL CIRCULATORY DEVICE. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR STATED THAT AN EVOLUT VALVE DID NOT CAUSE OR CONTRIBUTE TO THE NEED FOR PCI. HOWEVER, NO EVIDENCE WAS PROVIDED TO CORROBORATE THIS STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560495 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H