BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23161606 · Received September 26, 2025

    Report

    Report Number
    9617601-2025-01643
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    May 27, 2025
    Report Date
    September 26, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: STURLA ET AL. IMPACT OF AORTIC LANDING ZONE GEOMETRY ON TAVI IMPLANTATION DEPTH: COMPARISON BETWEEN ACURATE NEO2 AND PORTICO/EVOLUT. OPEN HEART. 2025 MAY 27;12(1):E003181. DOI: 10.1136/OPENHRT-2025-003181. 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 THE IMPACT OF AORTIC LANDING ZONE GEOMETRY ON TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IMPLANTATION DEPTH.  THE STUDY POPULATION INCLUDED 207 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS OLD.  MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED EVOLUT R AND EVOLUT PRO+ BIOPROSTHETIC VALVES.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS THAT MAY HAVE OCCURRED IN ASSOCIATION WITH THE VALVE INCLUDED: VASCULAR COMPLICATIONS, MODERATE TO SEVERE PARAVALVULAR LEAK (PVL), ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, AND STROKE.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS THAT MAY HAVE OCCURRED DURING USE OF THE DELIVERY CATHETER SYSTEM (DCS) INCLUDED: ACCESS SITE COMPLICATION REQUIRING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH STENT PLACEMENT.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936761 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 82 YR Female Required Intervention| H| L