BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 19201339 · Received April 29, 2024

    Report

    Report Number
    9612164-2024-02032
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    December 30, 2023
    Report Date
    April 29, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: SALVAGE OF AN INCOMPLETE SANDWICH WITH A COVERED CELIAC TRUNK AND A ¿FLOATING¿ SUPERIOR MESENTERIC ARTERY STENT IN A THORACOABDOMINAL AORTIC ANEURYSM GOUVEIA E MELO ET AL, OURNAL OF ENDOVASCULAR THERAPY 2023, VOL. 30(6) 951¿956 HTTPS://DOI.ORG/10.1177/15266028221090448 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

    A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR REPAIR OF 79MM TYPE V TAAA USING A SANDWICH TECHNIQUE (CHIMNEY FOR THE CELIAC TRUNK (CT) AND SUPERIOR MESENTERIC ARTERY (SMA).) ON AN UNKNOWN DATE. NON MEDTRONIC GRAFTS WERE ALSO IMPLANTED DURING THE PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE NAVION GRAFT WAS IMPLANTED LOWER THAN INTENDED COVERING THE CELIAC TRUNK. THE SMA WAS STENTED WITH A NON MEDTRONIC STENT AND LEFT INSIDE THE MAIN THORACIC GRAFT, WITHOUT COMPLETING THE SANDWICH TECHNIQUE. A SECOND ATTEMPT WAS MADE AT CATHETERIZING THE CT TO COMPLETE THE REPAIR BUT WAS UNSUCCESSFUL AND THE PATIENT WAS REFERRED TO ANOTHER CENTER. CT-ANGIOGRAPHY AT THE REFERRING CENTER SHOWED A PATENT BUT COVERED CT, A PATENT SMA WITH A LONG STENT FACING UPWARD INSIDE THE THORACIC AORTIC GRAFT AND A SIGNIFICANT TYPE IB ENDOLEAK WHERE THE THORACIC GRAFT WAS NOT SEALING DISTALLY WITH NO INCREASE IN SIZE. A STAGED PROCEDURE WAS COMPLETED WHERE FIRSTLY THE AORTA EXTERNAL TO THE GRAFT WAS CATHARIZED FOLLOWED WITH CATECHIZATION OF THE CT. NON MEDTRONIC STENTS WAS PLACED INTO THE CT AND SMA AND CONTROL ANGIOGRAPHY SHOWED CORRECT PLACEMENT AND PATENCY OF BOTH SMA AND CT STENTS. THE PROCEDURE WAS COMPLETED BY COMPLETING A FENESTRATED AND BRANCHED REPAIR USING A NON-MEDTRONIC GRAFT WITH NO ENDOLEAKS OBSERVED. POSTOPERATIVE RECOVERY WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED 8 DAYS AFTER SURGERY. THE FIRST-MONTH CT-ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM, PATENCY OF ALL STENTS, AND TARGET VESSELS, WITH NO SIGNS OF TARGET VESSEL INSTABILITY, ENDOLEAKS, OR MURAL THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981094 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention