Description of event according to initial reporter.A patient of undisclosed gender and age underwent a tevar (thoracic endovascular aortic repair) procedure in which the zenith alpha thoracic endovascular graft proximal tapered components, was used.When the graft was unsheathed in the patient the third stent from the top would not open fully.It was constrained about fifty percent.The surgeon used a coda balloon to open the stent successfully.It was a dissection, patient had some tears in their aorta patient outcome: district manager contacted the surgeon one day post-op and surgeon confirmed the patient was doing well.
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Manufacturers (b)(4).Summary of investigational findings: a patient of undisclosed gender and age with dissection, underwent a tevar (thoracic endovascular aortic repair).In which, zta-pt-38-34-167-w (complaint device) was used.When the graft was unsheathed in the patient, the third stent from the top would not open fully.It was constrained about fifty percent.The surgeon used a coda balloon to open the stent successfully.No additional interventions were performed, due to this occurrence.Per, the reported information, the black safety-lock knob was turned in the direction of the arrows until a slight click was felt and the blue rotation handle turned in the direction of the arrow until a stop was felt, as per ifu (instructions for use).No difficulties were experienced, during rotation of the rotation handle.The stent graft implanted in the planned target zone.There was not any part of the procedure off label or out of patient selection criteria.District manager contacted, the surgeon one day post-op and surgeon confirmed, the patient was doing well.Review of the device history record gave no indication, of the device being produced out of specification.No imaging was provided.And no device was returned.Based on the provided information, it has not been possible to establish the cause of the incomplete expansion of the stent graft.It is noted, that zta device is used for treatment of dissection.Per the ifu (instructions for use): the zta, is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.And the safety and effectiveness of the zta have not been evaluated in the patients with dissections.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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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