W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Model Number 20059769 |
Device Problem
Material Deformation (2976)
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Patient Problem
Pseudoaneurysm (2605)
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Event Date 04/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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Event information such as item/lot number, implant date, date of explant, patient medical history was requested, however no information has been received.Due to an unknown lot/serial number and no device return, an investigation could not be performed.
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Event Description
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The following publication was reviewed; title: nonanastomotic pseudoaneurysm with complete disruption of an expanded polytetrafluoroethylene axillofemoral bypass graft.Source: annals of vascular surgery volume 26, issue 3, april 2012, pages 422.E9-422.E12.Article states: rupture of an expanded polytetrafluoroethylene (eptfe) vascular graft is rare.We report a non-anastomotic pseudoaneurysm associated with complete disruption of an eptfe graft that occurred 6 years after an axillofemoral bypass.The (b)(6)-year-old patient had undergone neither trauma nor infection.The aneurysmal segment was resected, and a new eptfe graft was interposed.The patient recovered uneventfully and was well 4 years later.Histologic analysis revealed a torn graft edge, consistent with a rupture due to excessive force, but scanning electron microscopy showed that the internal structure of the prosthesis was intact.The cause of the midgraft rupture remains unknown.
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Manufacturer Narrative
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The following publication was reviewed; title: non anastomotic pseudoaneurysm with complete disruption of an expanded polytetrafluoroethylene axillofemoral bypass graft.Source: annals of vascular surgery volume 26, issue 3, april 2012, pages 422.E9-422.E12.Article states: rupture of an expanded polytetrafluoroethylene (eptfe) vascular graft is rare.We report a non-anastomotic pseudoaneurysm associated with complete disruption of an eptfe graft that occurred 6 years after an axillofemoral bypass.The 81-year-old patient had undergone neither trauma nor infection.The aneurysmal segment was resected, and a new eptfe graft was interposed.The patient recovered uneventfully and was well 4 years later.Histologic analysis revealed a torn graft edge, consistent with a rupture due to excessive force, but scanning electron microscopy showed that the internal structure of the prosthesis was intact.The cause of the midgraft rupture remains unknown.
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