Model Number GELSOFT PLUS BIFURCATE |
Device Problems
Partial Blockage (1065); Stretched (1601); Material Twisted/Bent (2981); Insufficient Information (3190)
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Patient Problems
Pain (1994); Obstruction/Occlusion (2422)
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Event Date 01/23/2024 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer narrative: clinical code: 2422 - obstruction/occlusion: claudication reported as caused by graft dilation 16/8 - 22/11 and kinking of the left and right side.Impact code: 4624 - surgical intervention: surgical intervention: an endovascular thrombectomy of the external and common right iliac artery was performed using the rotarex system.During this procedure a bleeding occurred at the level of the external iliac artery on the right side.As such a stent-graft was implanted (vbx - gore).The stenotic proximal anastomosis was treated with a medtronic iliac limb graft 16/24mm (prestenotic aortic diameter - 12 mm.Stenosis 5mm.Graft posstenosis 22mm).During this procedure the left renal artery was partially occluded and required a stent implantation.The left graft iliac limb was treated because of the kinking through the implantation of an advanta stent 12/41mm.Medical device problem: 3190 - insufficient information: a/w additional information and scans form site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft sales from jan 19 to feb 24 vs gelsoft occlusion ( claudication ) jan 19 to feb 24 complaints) gave an occurrence rate of (b)(4)% 4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.4114 - device not returned: device remains implanted.
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Event Description
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Event reported from panther post market study as claudication : graft dilatation from 16/8 to 22/11, limb occlusion on the right side, limb dilatation and kinking on the left side.Claudication pain in right thigh after 500 meters, limb occlusion on the right side.Graft dilatation from 16/8 to 22/11, limb dilatation and kinking on the left side.Admitted to hospital (b)(6) 2024, discharged (b)(6) 2024.
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Manufacturer Narrative
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Manufacturer narrative: clinical code: 2422 - obstruction/occlusion: claudication reported as caused by graft dilation (b)(6) and kinking of the left and right side.1994 - pain - claudication pain.Impact code: 4625 - surgical intervention: surgical intervention: an endovascular thrombectomy of the external and common right iliac artery was performed using the rotarex system.During this procedure a bleeding occurred at the level of the external iliac artery on the right side.As such a stent-graft was implanted (vbx - gore).The stenotic proximal anastomosis was treated with a medtronic iliac limb graft 16/24mm (prestenotic aortic diameter - 12 mm.Stenosis 5mm.Graft posstenosis 22mm).During this procedure the left renal artery was partially occluded and required a stent implantation.The left graft iliac limb was treated because of the kinking through the implantation of an advanta stent 12/41mm.4614 - medical intervention - claudication / occlusion which required medical intervention.Medical device problem: 2981 - ct imaging showed kinking.2423 - obstruction of flow : occlusion reported 1601 - stretched - ct scans showed dilation of the graft.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft sales from jan 19 to feb 24 vs gelsoft occlusion ( claudication ) jan 19 to feb 24 complaints) gave an occurrence rate of (b)(4).4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.4114 - device not returned: device remains implanted.Investigation findings:- 213 - no device problem found - review of the retained manufacturing records show the graft was manufactured to specification.Investigation findings:- 4315 - cause not established - no causal link between the device and the event could be determined.
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Event Description
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This report is being submitted as follow up #1 for mfg report #9612515-2024-00016 to provide event closure information for comp no (b)(4).
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Search Alerts/Recalls
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