Manufacturers narrative section h6 health effect - clinical code: 4580 - insufficient information - gelweave bifurcate graft was implanted to treat aorto-femoral aneurysm.Shortly after procedure post-operative acute ischemia due to early occlusion of gelweave device identified.Health impact - impact code: 4625 - additional surgery- to resolve the event medication (unknown type) was given to the patient.Thrombus was removed from the device.12x38mm bentley stent was implanted in adrenal aorta above gelweave graft to avoid stenosis of anastomotic site.Medical device problem code: 2423 - obstruction of flow - thrombus was removed from the device.12x38mm bentley stent was implanted in adrenal aorta above gelweave graft to avoid stenosis of anastomotic site.Component code: 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or subassemblies.Type of investigation: 4110 - trend analysis.A similar event review was performed for occlusions in gelweave grafts between jan 19 and jun 23.A similar event rate of 0.006% was confirmed.No negative trend in the number of events was identified.4111 - communication/interviews - further information has been requested from the site.3331- analysis of production records - a review of manufacturing and quality control records confirmed that the device was manufactured to the intended specifications.Investigation findings: 213 - no device problem found - no issue has been found upon review of the retained device history records.Complainant aslo confirmed that the device was not kinked or twisted, also the patient did not have any allergies to the grafts components.Investigation conclusion: 4315 - cause not established- device showed occlusion approximately 3 hours after procedure.A thrombectomy was carried out and the graft remained patent afterwards.Patient recovered, event resolved without sequelae.
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