BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 19357528 · Received May 21, 2024

    Report

    Report Number
    9612164-2024-02417
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    October 17, 2023
    Report Date
    June 18, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Removal / Correction Number
    3005364322-02-19-2021-00
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    STENT GRAFT MIGRATION DUE TO STRUCTURAL FAILURE NINE MONTHS AFTER THORACIC ENDOVASCULAR AORTIC REPAIR USING VALIANT NAVION KAMADA ET AL, EJVES VASCULAR FORUM (2023) 60, 77E80 HTTPS://DOI.ORG/10.1016/J.EJVSVF.2023.10.002 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 STENT GRAFT MIGRATION DUE TO STRUCTURAL FAILURE NINE MONTHS AFTER THORACIC ENDOVASCULAR A ORTIC REPAIR USING VALIANT NAVION A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH ARCH VESSEL DEBRANCHING (AXIL LOEAXILLARY BYPASS WITH LEFT COMMON CAROTID ARTERY BYPASS) FOR A 73MM DISTAL ARCH ANEURYSM ON AN UNKNOWN DATE. THE PROXIMAL NECK DIAMETER WAS 39 MM. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT REVEALED STENT GRAFT MIGRATION. THERE WAS NO ENDOLEAK, BUT THE ANEURYSM HAD BECOME ENLARGED. ECHOCARDIOGRAPHY SHOWED THAT AORTIC VALVE STENOSIS HAD PROGRESSED TO MODERATE. BASED ON THESE FINDINGS, TAR AND AVR WERE CHOSEN AS THE SECONDARY SURGERY. DURING THE INTERVENTION THE VALIANT NAVION GRAFT WAS REMOVED FROM THE AORTA. A BROKEN STENT RING AND BROKEN SUTURE SEAMS WERE FOUND. A STENT RING FRACTURE WAS IDENTIFIED ON THE EXPLANTED GRAFT. THE INTERVENTION WAS COMPLETED USING NON MEDTRONIC GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE MIGRATION WAS SUSPECTED TO BE DUE TO THE STENT GRAFT FRACTURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426800 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention