(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously deployed stent while attempting to cross causing the reported resistance and subsequent stent dislodgement.The device was removed but met resistance with the guiding catheter causing the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) artery.There was resistance advancing an unspecified xience sierra stent delivery system (sds) through a previously implanted unspecified stent.The sds was then pulled back through the guiding catheter when resistance was felt and the sds became stuck with the guiding catheter.The sds was able to be removed through the guiding catheter.However, when the sds was removed, the stent was not on the balloon.The stent dislodged into the lad, outside the target lesion.An attempt was made to retrieved the dislodged stent with a snare, but failed.And therefore, an unspecified guide wire was advanced alongside the dislodged stent and crushed it against the vessel wall with an unspecified stent.Another unspecified stent was deployed to treat the target lesion.There was no patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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