The device history records are being reviewed.The event is currently under investigation.The information provided represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient, product, or procedural details.
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The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device, the reported event could not be confirmed.The stent graft was found to be completely loaded in the system.During the performed function test, the stent graft could be released.No device deficiency that may have led to the reported event was identified.For this reason, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy or challenging placement site.Reportedly, the lesion had been pre-dilated.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure." and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, the ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.".
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