BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3055323 · Received April 12, 2013

    Report

    Report Number
    2953200-2013-00672
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT ON THE FINAL ANGIOGRAM A TYPE III FABRIC ENDOLEAK WAS NOTED. THE PHYSICIAN DECIDED TO RELINE THE STENT GRAFT WITH ANOTHER VALIANT 3232150 AND THIS REDUCED THE ENDOLEAK; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159142 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01006512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention