BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT NAVION

    MDR report key: 19319485 · Received May 15, 2024

    Report

    Report Number
    9612164-2024-02319
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 24, 2023
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; LOWER-PROFILE STENT GRAFT REDUCES THE RISK OF EMBOLISM DURING THORACIC ENDOVASCULAR AORTIC REPAIR IN SHAGGY AORTA SEIKE Y, MASADA K, FUKUDA T, YOKAWA K, KOIZUMI S, KASAI M ET AL INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 2023, 36(5) HTTPS://DOI.ORG/10.1093/ICVTS/IVAD058 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. 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

    THIS STUDY AIMED TO REVEAL THE ASSOCIATION BETWEEN LOWER-PROFILE STENT GRAFT (LPSG) AND EMBOLISM DURING THORACIC ENDOVASCULAR AORTIC REPAIR FOR NON-DISSECTING DISTAL ARCH AND DESCENDING THORACIC AORTIC ANEURYSM. THIS STUDY REVIEWED DATA OF 35 PATIENTS WHO UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR WITH LPSG AND 312 WHO UNDERWENT THORACIC E NDOVASCULAR AORTIC REPAIR WITH CONVENTIONAL-SIZED STENT GRAFT OVER A TWO YEAR PERIOD. IN THE LPSG  GROUP, VALIANT NAVION STENT GRAFTS AND NON MDT STENT GRAFT WERE IMPLANTED WHILE IN THE CONVENTIONAL-SIZED STENT GRAFT GROUP, VALIANT CAPTIVIA AND NON MDT STENT GRAFTS WERE IMPLANTED.  THE FOLLOWING MALFUNCTIONS WERE REPORTED IN BOTH GROUPS; TYPE I ENDOLEAK, TYPE III ENDOLEAK  IN THE LOWER-PROFILE STENT GRAFT (LPSG) GROUP THE FOLLOWING ADVERSE EVENTS WERE REPORTED; ACCESS SITE INJURY, PNEUMONIA, INTERVENTION IN THE CONVENTIONAL-SIZED STENT GRAFT GROUP, THE FOLLOWING ADVERSE EVENTS WERE REPORTED;  TYPE B DISSECTION, STROKE, SPINAL CORD ISCHEMIA, DISTAL EMBOLISM, ISCHAEMIC PANCREATITIS, IRREVERSIBLE RENAL DYSFUNCTION, ISCHAEMIC COLITIS, SURGICAL SITE HEMATOMA REMOVAL, PNEUMONIA, ACCESS SITE INJURY, INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MEDTRONIC STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477713 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-NAV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown