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An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 50mm abdominal aortic aneurysm.It was decided pre-operatively the approach via the patients left femoral artery would be most beneficial due to the angulation of aortic neck.It was reported during the index procedure, the physician performed cutdowns to the left and right common femoral arteries.Using a thin-walled needle, access was made to the right femoral artery and a.035" (non medtronic) wire was advanced under fluoroscopy.The thin-walled needle was removed over the wire.A hemostatic sheath was inserted into the vessel over the wire.A marker flush catheter was advance over the.035" wire to the level of l1, and the wire was removed.The marker flush catheter was connected to a power injector with a wet to wet connection.The physician then gained access to the left femoral artery using a thin-walled needle and advanced a.035" wire under fluoroscopy.The thin-walled needle was removed over the wire, and a hemostatic sheath was inserted into the left femoral artery over the wire.A directional catheter was back-loaded onto the.035"wire.The.035" wire was advanced followed by the directional catheter into the thoracic aorta.The.035" wire was removed, and a stiff.035" wire was advanced to the proximal descending thoracic aorta.The hemostatic sheath was removed from the left femoral artery over the wire.The esbf2514c103e delivery system was advanced over the stiff.035" wire to the level of t-12.The c-arm angles changed to an optimal position to view the renal arteries.Using the marker flush catheter through the right femoral artery access, a contrast injection was made under subtraction angiography.The renal arteries were located and marked on the monitor.The physician then began the deployment of the esbf2514c103e bifurcate stent graft,which was deployed bare-back (without a sheath.).When positioned at the desired location, the super-renal fixation was released, with the ipsi-lateral gate still constrained.It was noticed that the super-renal fixation struts had not expanded completely.Using the marker flush catheter, subtraction angiography was performed.The physician noted the flow to the right renal artery was sluggish.Using a.035" wire, the marker flush catheter was straightened and pulled down to the level of the contra-lateral gate.Contra-lateral gate cannulation was attempted using several directional catheters as well as a steerable guide without success.The physician deployed the remainder of the esbf2514c103e past the ipsi-lateral gate.The delivery system was the advanced over the wire bringing the spindle superior to the super-renal fixation struts.The top cap was closed on the delivery system, and was removed over the wire.A 16 fr.Sentrant sheath (lot # 00157732) was then inserted over the wire.The marker flush catheter was then advanced over the wire from the left side.The physician used the marker flush catheter along with an contrast injection through the left sheath to determine the limb length needed.The marker flush catheter was then removed over the wire.A etlw1616c124 was inserted over the wire, through the 16fr.Sheath in the left femoral artery, to the correct position.The etlw1616c124 was deployed.The etlw1616c124 delivery system was re-made, and removed.A second.035" wire was inserted, through the 16 fr.Sheath in the left femoral artery, along with a directional catheter.The wire was then advanced to the flow divider of the esbf2514c103e.A snare was inserted via the sheath in the right femoral artery, and position at the level below the contra-lateral gate.Using the directional catheter, the wire was advanced on the left side down the contra-lateral gate.The wire would not advance beyond the contra-lateral gate.The physician advanced the marker flush catheter over the.035" stiff wire above the level of the renal arteries.Subtraction angiography was used.The bifurcated graft was noted to be deployed in the false lumen and the proximal portion of the limb was deployed inside the ipsi-lateral gate of the bifurcated graft.The distal portion of the limb was in the true lumen of the left common iliac artery.The physician then converted to an open repair.While performing the open surgical repair the patient went into cardiac arrest and was not able to be revived.The stent grafts were explanted.It was reported the cause of the event was that the non medtronic.035" wire, inserted through the sheath in the left femoral artery, had gone sub-intimal for a unknown distance.A false lumen not present on pre-operative cta.It was said the esbf2514c103e device delivery system functioned correctly.The complications arose from the wire's location no additional clinical sequalae were provided and the patient is expired.
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Film evaluation summary: the reported inaccurate delivery and inability to cannulate event could not be confirmed on the films provided; therefore the cause of the event.Procedural angiogram showing deployment of the device were not received for a thorough analysis of the event.It is likely as reported that the insertion of the wire sub-intimally was related to the events.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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