Manufacturer ref# (b)(4).Summary of investigational findings: a 70 years old male patient with dissection in visceral arteries should undergo tevar with zta-pt-32-28-178-w.It was reported that the physician unsheathed the device in an operation table and were in the process of removing the barbs at the proximal end of the graft.This was done by using a heavy duty needle driver and twisting off the barbs.It was noticed that an apex of bare alignment stent was not fixed to the graft material.The physician sutured apex to the graft, reloaded the stent graft and deployed it into the patient.No adverse events were reported.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.Moreover, it states that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in the patients with dissections.The instructions for use also states, that the extreme caution should be exercised, when manipulating interventional and angiographic devices in the region of the uncovered proximal stent and uncovered distal stent.Per the instructions for use, it must not be attempted to resheath the graft after partial or complete deployment.Furthermore, the device must not be used if damage has occurred.Instead, it should be return to cook.Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient.Based on the provided information, imaging and cook´s documentation, an exact cause of the reported event cannot be established.However review of the device history record gave no indication of the device being produced out of specification.It is possible that the damage occurred during design modification.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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