BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3100488 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00860
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: INHERENT RISK OF A PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE OF 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 ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. THERE WERE NO COMPLICATIONS REPORTED DURING THE PROCEDURE. A CTA CONTROL WAS PERFORMED ONE WEEK POST IMPLANT AND AN ENDOLEAK WAS NOTED. BASED ON THE IMAGES THE PHYSICIAN THOUGHT THIS WAS A TYPE III ENDOLEAK (A POSSIBLE TEAR IN THE FABRIC). NO INTERVENTION WAS PERFORMED AT THIS TIME. ANOTHER CONTROL WAS PERFORMED APPROXIMATELY TWO WEEKS LATER AND CONFIRMED THAT THE ENDOLEAK HAD RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REVIEW OF RETURNED FILMS 4-DAYS POST-IMPLANT SHOW THAT THE STENT GRAFT WAS POSITIONED FROM JUST DISTAL TO THE LSA, INTO THE DESCENDING THORACIC. APPROXIMATELY 2CM DISTAL TO THE STENT GRAFT PROXIMAL GRAFT MARGIN, JUST DISTAL TO THE TOP OF THE ARCH, THERE IS A LIKELY ENDOLEAK SEEN ON THE MEDIAL SIDE WHICH APPEARS TO BE A TYPE III FABRIC ENDOLEAK. CANNOT RULE OUT A PROXIMAL TYPE I OR A TYPE IV. NO OTHER STENT GRAFT ISSUES ARE SEEN. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED. ADDITIONALLY 3 D RECONSTRUCTION IMAGING WAS PERFORMED AND STATED THE ENDOLEAK WAS DISCOVERED IN SCAN SEVEN DAYS POST IMPLANT. PROBABLE TYPE III FABRIC ENDOLEAK. NO STENT BREAKAGE, ADJACENT CALCIUM DEPOSIT, OR OTHER ASSIGNABLE CAUSE FOR THE ENDOLEAK. THE ENDOLEAK LOCATION IS POSSIBLY ASSOCIATED WITH THE LONGITUDINAL SEAM IN THE DEVICE FABRIC, BUT IT IS IMPOSSIBLE TO CONFIRM FROM THE SCAN. ENDOLEAK RESOLVED WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201241 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01696004

    Patients

    Seq Age Sex Outcome Treatment
    1