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Device Problem
Complete Blockage (1094)
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Patient Problem
Thrombosis (2100)
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Event Date 05/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Case # 2 is being reported under mfr report # 2017233-2020-00372.
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Event Description
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The following information was reported to gore: in an article titled "arteriovenous graft delamination and dissection as a cause of graft dysfunction" it states a woman receiving hemodialysis presented with av graft thrombosis 3 months after implantation of a gore® hybrid vascular graft.Thrombectomy was performed with an arrow-trerotola percutaneous thrombectomy device.After flow was restored angiography showed several mild focal intragraft stenoses and filling defects within the venous limb, which were treated with repeated thrombectomy and balloon-angioplasty.Repeated angiography showed greater prominence of these lesions with no improvement in appearance.Thrombectomy was then attempted with a compliant balloon, but after balloon deflation the original filling defect was still there.Color doppler ultrasonography showed dissection, infolding and stagnant flow within the false lumen.Overlapping fluency and smart stents were deployed across these flow-limiting dissections.Four weeks after hemodialysis was removed, the av graft rethrombosed.After percutaneous thrombectomy, additional lucent areas compatible with graft dissections in the venous limb were identified and treated with stent deployment.Although hemodialysis was resumed, the graft subsequently thrombosed and was then abandoned.Literature citation: dai r, broadwell sr, lessne ml, kim cy.Arteriovenous graft delamination and dissection as a cause of graft dysfunction.Journal of vascular & interventional radiology 2020;31(5):852-854.E1.
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Event Description
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The following information was reported to gore: in an article titled "arteriovenous graft delamination and dissection as a cause of graft dysfunction" it states a woman receiving hemodialysis presented with av graft thrombosis 3 months after implantation of a gore® hybrid vascular graft.Thrombectomy was performed with an arrow-trerotola percutaneous thrombectomy device.After flow was restored angiography showed several mild focal intragraft stenoses and filling defects within the venous limb, which were treated with repeated thrombectomy and balloon-angioplasty.Repeated angiography showed greater prominence of these lesions with no improvement in appearance.Thrombectomy was then attempted with a compliant balloon, but after balloon deflation the original filling defect was still there.Color doppler ultrasonography showed dissection, infolding and stagnant flow within the false lumen.Overlapping fluency and smart stents were deployed across these flow-limiting dissections.Four weeks after hemodialysis was resumed, the av graft rethrombosed.After percutaneous thrombectomy, additional lucent areas compatible with graft dissections in the venous limb were identified and treated with stent deployment.Although hemodialysis was resumed, the graft subsequently thrombosed and was then abandoned.Literature citation: dai r, broadwell sr, lessne ml, kim cy.Arteriovenous graft delamination and dissection as a cause of graft dysfunction.Journal of vascular & interventional radiology 2020;31(5):852-854.E1.
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Manufacturer Narrative
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Event updated.
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Search Alerts/Recalls
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