On (b)(6) 2020, the patient underwent an endovascular branched endovascular aortic repair (bevar) with a customized fenestrated/ branched stent graft component (cook medical) because of a thoracoabdominal aneurysm type iv.The following branches were treated with one gore¿ viabahn¿ vbx balloon expandable endoprosthesis (viabahn¿ vbx device) each: celiac artery, left renal artery, right renal artery, and superior mesenteric artery.A gore¿ viabahn¿ endoprosthesis with propaten bioactive surface (viabahn¿ device) was used to extend the viabahn¿ vbx device implanted in the superior mesenteric artery distally.Access was gained via a cut down to the axillary artery to implant the viabahn¿ vbx devices and the viabahn¿ device.Reportedly, the procedure was very complex because of the anatomy.A very small endoleak occurred at the ostium of the left renal artery which was resolved during the procedure.They suspected that a pre-existing large calcification at the ostium of the left renal artery may have contributed to this small endoleak.On (b)(6) 2021, the patient was diagnosed a type 2 endoleak related to the customized fenestrated/ branched stent graft component (cook medical), a type 3 endoleak from the left renal artery branch, a type 1c endoleak from the superior mesenteric artery branch, and a stenosis (50 %) of the celiac trunk branch.Reportedly, they suspected that these complications may be related to the complex procedure and the pre-existing large calcification.Reportedly, they do not suspect the complications to be caused by the implanted devices.They noted that this anatomical location is also stressed by respiratory motion which may have favored the formation of the endoleaks and the stenosis of the celiac trunk.On (b)(6) 2021, an endovascular reintervention was performed to resolve the endoleaks and the stenosis successfully.It was stated that the event was resolved without sequelae.
|
H6-code 4111: requests were emailed to the physician to provide dicom images (pre, peri/intra, post) for evaluation.The requests remained unanswered.Therefore an imaging evaluation could not be performed.With no additional information provided, gore is unable to perform further investigations of this event.Four (4) devices are involved in this event.Therefore, in total four (4) medwatch reports have been submitted: - manufacturer report number 2017233-2021-02419.- manufacturer report number 2017233-2021-02416.- manufacturer report number 2017233-2021-02417.- manufacturer report number 2017233-2021-02418.
|