BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23300116 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-02018
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 15, 2025
    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
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PARK HS, SUH CH, AHN JM, ET AL. EFFECT OF CEREBRAL EMBOLIC PROTECTION DEVICE ON NEW CEREBRAL EMBOLISM DURING TRANSCATHETER AORTIC VALVE REPLACEMENT: A PROSPECTIVE SENTINEL REGISTRY. AM HEART J. 2026;291:44-52. DOI:10.1016/J.AHJ.2025.08.006 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE EFFECTIVENESS OF A CEREBRAL EMBOLIC PROTECTION (CEP) DEVICE IN PREVENTING NEW CEREBRAL LESIONS DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 49 PATIENTS WHO UNDERWENT TAVR WITH A CEP DEVICE (CEP GROUP) AND 170 PATIENTS WHO UNDERWENT TAVR WITHOUT A CEP DEVICE (CONTROL GROUP). ONLY NON-MEDTRONIC BALLOON-EXPANDABLEVALVES (SAPIEN 3 OR 3 ULTRA) WERE USED IN THE CEP GROUP. IN THE CONTROL GROUP, A MIX OF MEDTRONIC SELF-EXPANDABLE VALVES (EVOLUT R OR PRO = 11) AND NON-MEDTRONIC BALLOON-EXPANDABLE VALVES (SAPIEN 3 OR 3 ULTRA = 159) WERE USED. THE FOLLOWING ADVERSE OUTCOMES OCCURRED IN THE CONTROL GROUP: NEW CEREBRAL LESIONS, NONDISABLING STROKE, BLEEDING, MAJOR VASCULAR COMPLICATIONS, PERMANENT PACEMAKER IMPLANTATION, AND REHOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994017 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 81 YR Female Hospitalization| R| L