BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

    MDR report key: 24900001 · Received April 16, 2026

    Report

    Report Number
    9612164-2026-01993
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    September 17, 2025
    Report Date
    April 16, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MEZIER ET AL. SNARE CATHETER TECHNIQUE IN COMPLEX TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURES. ARCH CARDIOVASC DIS. 2026 MAR;119(3):210-215. DOI: 10.1016/J.ACVD.2025.08.009. EPUB 2025 SEP 17. 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 SNARE CATHETER TECHNIQUE IN COMPLEX TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURES. THE STUDY POPULATION INCLUDED FIVE PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 79.6 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; FOUR OF THE PATIENTS RECEIVED A MEDTRONIC EVOLUT PRO+ BIOPROSTHETIC TRANSCATHETER VALVE DELIVERED VIA DELIVERY CATHETER SYSTEM (DCS). ALL FIVE CASES INCLUDED DCS ADVANCEMENT DIFFICULTY DUE TO EXCESSIVE CALCIFICATION, CHALLENGING ANATOMY, OR ENTANGLEMENT WITH A PREVIOUSLY IMPLANTED PROSTHETIC VALVE. AMONG EVOLUT PRO+ PATIENTS, CLINICAL OBSERVATIONS INCLUDED: ACCESS SITE HEMATOMA WITH PROLONGED BLEEDING AND ISCHEMIC STROKE IN ONE PATIENT, AND DCS NOSE CONE DETACHMENT FROM THE DEVICE CAPSULE IN ANOTHER PATIENT. ALL CASES WERE RESOLVED WITH THE USE OF A SURGICAL SNARE TO ASSIST IN MANEUVERING THE DCS TO THE INTENDED TARGET. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304874 MEDTRONIC TRANSCATHETER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND MDT-TRANS DCS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R| L