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W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC
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| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problem
No Code Available (3191)
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| Event Date 04/30/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Patient age: mean age 71 years.Patient gender: vast majority is male.Date the events occurred are unknown, so the date the article was accepted was used as date of event.(b)(4).
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Event Description
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The following literature article was reviewed: "first/preliminary experience of gore viabahn balloon-expandable endoprosthesis as bridging stent in fenestrated and branched endovascular aortic repair".Enrico gallitto, mauro gargiulo, et al.Ann vasc surg 2019; 61: 299¿309 https://doi.Org/10.1016/j.Avsg.2019.04.049 manuscript received: march 2, 2019; manuscript accepted: april 30, 2019; published online: 31 july 2019.The aim of this study is to evaluate the preliminary outcomes of the gore® viabahn® vbx balloon expandable endoprosthesis (vbx endoprosthesis) as bridging stent for fenestrated/branched aortic endograft.Fifteen prospectively collected patients undergoing fenestrated and branched-endovascular aortic repair (zenith® platform, cook medical) for juxta/pararenal aneurysms (11), proximal type i endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study.In total 40 vbx endoprostheses have been implanted in the celiac trunk (ct, 7), the superior mesenteric artery (sma, 9), the renal artery (ra, 22) and the hypogastric artery (ha, 2).In the article it is stated, that the most frequent vbx size used for fenestrations were 6-7 mm in diameter and 29 mm in length for renal arteries.For sma and ct, it was 8-9 mm in diameter and 29 mm in length.For branched endograft, the most frequent choice was 8-9 mm in diameter and 59-79 mm in length.Considering the choice of the stent-graft diameter, the manufacturer instructions for use suggests that the semicompliant covered balloon enables diameter customization.According to this characteristic, it should be possible to customize the stent-graft diameter according to the vessel diameter on the basis of the pressure of inflation.In the present study, we have not followed this principle since our bridging stent graft is usually planned according to the vessel diameter at the preoperative computed tomography angiography (cta), with no intended oversizing.Further it is stated in the article, that to reduce the risk of spinal cord ischemia the aneurysm exclusion is obtained in two steps.In the first step, we usually deploy the aortic endografts (thoracic + fenestrated branched modules + abdominal and iliac segments) and connect all the side-branches/fenestrations to the native visceral vessels except one, usually that of the celiac trunk.Through this branch, a temporary type iii endoleak guarantees the flow in the aneurysm sac and thus the spinal cord perfusion.The second step procedure is performed 2-3 weeks after the initial procedure, with exclusion of the aneurysm by connecting the branch to the celiac trunk.The article includes the following case: in one patient an acute renal artery dissection, which occurred distally to the vbx endoprosthesis, was detected intraoperatively and was successfully managed during the initial procedure.The dissected renal artery had a diameter of 5.5 mm while the vbx endoprosthesis had a diameter of 6 mm.The dissection occurred after deployment and flaring of the vbx endoprosthesis.The complication was successfully solved by the deployment of a nitinol self-expandable bare metal stent between the vbx endoprosthesis and the distal segment of the native artery.In the article it is stated, that this occurrence should warn against the risk associated with the deployment of a balloon-expandable stent graft in small diameter renal arteries, since oversizing may lead to the dissection at the frontier between the stent and the native artery.
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Manufacturer Narrative
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The date of event was updated to the date the literture was accepted.
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Manufacturer Narrative
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The following literature article was reviewed: "first/preliminary experience of gore viabahn balloon-expandable endoprosthesis as bridging stent in fenestrated and branched endovascular aortic repair" enrico gallitto, mauro gargiulo, et al.Ann vasc surg 2019; 61: 299¿309 https://doi.Org/10.1016/j.Avsg.2019.04.049.Manuscript received: march 2, 2019; manuscript accepted: april 30, 2019; published online: 31 july 2019.Two further literatures were identified, reportíng the same incident, attached: 1) title "preliminary study of the gore viabahn stentgraft as a bridge between branched or fenestrated stentgrafts and target arteries", mauro gargiulo, enrico gallitto et al., 34th annual meeting of the french society for vascular and endovascular surgery, lille, june 27-30, 2019, https://doi.Org/10.1016/j.Avsg.2019.08.003.2) title "steerable sheath for cannulation and bridging stenting of challenging target visceral vessels in fenestrated and branched endografting", enrico gallitto, gianluca faggioli et al., article in press, ann vasc surg 2020; 1¿9, manuscript received: october 12, 2019; manuscript accepted: november 25, 2019; https://doi.Org/10.1016/j.Avsg.2019.11.039.Another reportable incident is related to literature https://doi.Org/10.1016/j.Avsg.2019.04.049: 44358 (mfr report # 2017233-2020-00170).H6-code 3221: the requests to the author remain unanswered.The lot numbers remain unknown.Without additional information, gore was unable to do further investigation of this event.
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