W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC
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Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Code Available (3191)
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Event Date 08/05/2019 |
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.Date of implant is unknown, so the date the study started was used as the date of implant.(b)(4).
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Event Description
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The following literature article was reviewed: "outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair" giovanni federico torsello et al.Journal of vascular surgery.Article in press.Submitted mar 25, 2019; accepted oct 24, 2019; available online jan 19, 2020.Https://doi.Org/10.1016/j.Jvs.2019.10.089.Presented in part at the 2019 leipzig interventional course (linc 2019), leipzig, germany, january 22-25, 2019.The purpose of this single-center, non-randomized study was to evaluate the clinical performance of the well-known advanta/icast v12 (getinge maquet) and the new gore® viabahn® vbx balloon expandable endoprosthesis in complex fenestrated and branched endovascular aortic aneurysm repair in combination with off-the-shelf branched (t-branch; cook medical) and custom-made fenestrated and branched stent grafts (zenith fenestrated or branched; cook medical).Between december 2017 and july 2018, there were 50 patients (40 male; mean age, 71 years) included.Retrospective analysis of prospectively collected data was performed.The following numbers of stent grafts of various manufacturers were implanted in total 198 side branches: 145 viabahn® vbx balloon expandable endoprosthesis.57 advanta v12.29 gore® viabahn® endoprosthesis with propaten bioactive surface.28 bare-metal stents (protégé everflex, medtronic; smart flex, cordis).The viabahn® vbx balloon expandable endoprosthesis was mainly implanted for bridging long distances and where flexibility was required.The bare-metal stents were implanted as an additional device for relining in case the bridging device did not reach the desired position in the target vessel or did not conform to the target vessel shape.The following numbers of side branches were exclusively sealed with gore® viabahn® vbx balloon expandable endoprostheses: 27 celiac trunk.25 superior mesenteric artery.74 renal arteries.Eight additional branches were treated with one of the above mentioned devices: 1 inferior mesenteric artery.1 isolated common hepatic artery.1 accessory left renal artery.5 accessory right renal arteries.Completion angiography showed primary patency of all target vessels.Within the article it was reported, that in one patient the gore® viabahn® vbx balloon expandable endoprosthesis place in the left renal artery occluded/thrombosed four days after the branched endovascular repair.It was stated that this complication was asymptomatic and detected at control computed tomography.The occlusion was treated by aspiration thrombectomy and relining with a self-expanding bare metal nitinol stent.
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Manufacturer Narrative
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Updated list of events are related to these literatures: (b)(6), (mfr report # 2017233-2020-00162).(b)(6), (mfr report # 2017233-2020-00163).(b)(6), (mfr report # 2017233-2020-00164).(b)(6), (mfr reports # 2017233-2020-00167; # 2017233-2020-00166; # 2017233-2020-00165).(b)(6), (mfr report # 2017233-2020-00168).
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Manufacturer Narrative
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The following literature articles were reviewed: "outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair" giovanni federico torsello et al.Journal of vascular surgery.Article in press submitted mar 25, 2019; accepted oct 24, 2019; available online jan 19, 2020 https://doi.Org/10.1016/j.Jvs.2019.10.089 presented in part at the 2019 leipzig interventional course (linc 2019), leipzig, germany, january 22-25, 2019.P-309."initial clinical experience with the gore viabahn balloon-expandable (vbx) stent-graft in branched and fenestrated endovascular aortic repair" e.Beropoulis et al., st.Franziskus-hospital münster journal: cardiovascular & interventional radiology (this was a poster abstract originally presented at cirse 2019 in barcelona).Date published: august 5, 2019.Multiple events are related to these literatures: 44246 (mfr report # 2017233-2020-00162) 44248 (mfr report # 2017233-2020-00163) 44267 (mfr report # 2017233-2020-00164) 44268 (mfr report # 2017233-2020-00167) 44270 (mfr report # 2017233-2020-00168).D6: the date of implant remains unknown.So this field was cleared.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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