BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3121004 · Received May 20, 2013

    Report

    Report Number
    2953200-2013-00937
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    December 13, 2011
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, STROKE. TYPE II LEAK. CONCLUSIONS: TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION UNDER PHYSICIAN-SPONSORED IDE # (B)(4). ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S POST-OPERATIVE COURSE WAS COMPLICATED DUE TO A LEFT FRONTAL LOBE CVA/STROKE RESULTING IN SLIGHT RIGHT FACIAL DROOPING. THE PATIENT WAS DISCHARGED TEN DAYS LATER WITH INSTRUCTIONS FOR FOLLOW-UP WITH THE NEUROLOGIST AND A SPEECH THERAPIST. THE PATIENT PRESENTED TWO MONTHS POST INDEX PROCEDURE WITH A DIAGNOSIS OF LEFT NECK FLUID COLLECTION, LIKELY SEROMA. A CT GUIDED NECK FLUID DRAINAGE THE FOLLOWING DAY WAS PERFORMED AND ANOTHER CT SCAN OF THE CHEST DURING THIS ADMISSION SHOWED A TYPE II ENDOLEAK COMING FROM THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN USED ANOTHER MANUFACTURER¿S VASCULAR PLUG FOUR DAYS LATER TO SUCCESSFULLY RESOLVE THE TYPE II ENDOLEAK. SEVEN MONTHS LATER THE CT OF THE CHEST SHOWED A TYPE I ENDOLEAK WITH DECREASED CONTRAST IN THE FALSE LUMEN AS COMPARED TO THE PREVIOUS STUDIES. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT AND IS BEING FOLLOWED BY THE REFERRING PHYSICIANS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222641 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention