BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 3944219 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01407
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 26, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CHRONIC RENAL INSUFFICIENCY WAS OBSERVED AGAIN 5 YEARS LATER. ADDITIONAL PATIENT HISTORY; EPILEPSY AND ASA CLASSIFICATION OF III. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER THORACIC AORTA ANEURYSM IN ZONE 4. VESSEL MORPHOLOGY WAS REPORTED AT THE TIME OF INDEX PROCEDURE THE LENGTH OF PROXIMAL THORACIC AORTA IS 20 MM THE DIAMETER OF THE PROXIMAL AORTIC NECK IS 30 MM. THE PATIENT HAD A REVASCULARIZATION OF CELIAC TRUNK DURING THE INDEX PROCEDURE. THE STENT GRAFTS WERE IMPLANTED WITHOUT ISSUE. IT WAS REPORTED THAT ONE MONTH LATER THE PATIENT HAD RENAL INSUFFICIENCY. THE INVESTIGATOR INDICATED THAT THE RENAL ARTERY ISSUE IS RELATED TO THE PROCEDURE NOT RELATED TO THE DEVICE. THE PATIENT WAS TREATED WITH MEDICATION HOWEVER THE RENAL ISSUE HAS NOT RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422388 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3434C100TE V04224767

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention