BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 22237836 · Received June 17, 2025

    Report

    Report Number
    2025587-2025-04282
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CAVAZZA ET AL. TRANSAXILLARY TAVR COMPLICATED BY SUBCLAVIAN PSEUDOANEURYSM AND VERTEBRAL ARTERY SACRIFICE. JACC CASE REP. 2025 JUN 4;30(13):103610. DOI: 10.1016/J.JACCAS.2025.103610. 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 AN 87-YEAR-OLD FEMALE PATIENT WITH AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A MEDTRONIC 23-MM EVOLUT FX BIOPROSTHETIC VALVE. DURING THE IMPLANT PROCEDURE, THE VALVE WAS DELIVERED BY DELIVERY CATHETER SYSTEM IN THE CORRECT POSITION WITH OPTIMAL HEMODYNAMIC PARAMETERS. HOWEVER, FINAL ANGIOGRAPHY REVEALED AN EXTENSIVE DISSECTION AT THE DISTAL ONE-THIRD OF THE SUBCLAVIAN ARTERY WHICH WAS TREATED WITH PLACEMENT OF A NON-MEDTRONIC SELF-EXPANDING STENT. ONE DAY POST-IMPLANT THE PATIENT EXHIBITED APHASIA AND ORAL COMMISSURE DEVIATION. COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) OF THE INTRACRANIAL VESSELS REVEALED SMALL HYPODENSE AREAS CONSISTENT WITH SUBACUTE ISCHEMIC STROKE AS WELL AS PSEUDOANEURYSM OF THE SUBCLAVIAN ARTERY AT THE PROXIMAL EDGE OF THE STENT. ONE DAY LATER THE PATIENT SHOWED COMPLETE REGRESSION OF NEUROLOGIC SYMPTOMS. A FOLLOW-UP CTA REVEALED AN ENLARGED PSEUDOANEURYSM NEAR THE PROXIMAL EDGE OF THE STENT. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO TREAT THE PSEUDOANEURYSM WITH PLACEMENT OF ANOTHER NON-MEDTRONIC COVERED STENT. THE PATIENT TOLERATED THE INTERVENTION WELL AND WAS DISCHARGED COMPLETELY ASYMPTOMATIC AND IN EXCELLENT NEUROLOGIC CONDITION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520888 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Life Threatening| R| H