It was reported that the procedure was to treat a lesion in the tortuous right coronary artery (rca).A 2.25x28mm xience nano stent delivery system (sds) was successfully advanced and the stent was successfully deployed in the proximal lesion.A second 2.25x28mm xience nano sds was dipped in saline prior to use and negative prep was performed inside the patient's anatomy.During advancement through the deployed stent to treat the distal lesion, the stent implants became caught.The second xience nano sds could not be advanced or removed.The guiding catheter was deep-seated in an attempt to disengage the two stents; however, this was unsuccessful.An attempt was made to deploy the stent in its current position; however, the device failed to inflate and a balloon leak was noted.Although force was applied, further attempts to withdraw the device were unsuccessful.The guiding catheter was removed and the sheath was changed from a 6-french to an 8-french.All devices were then removed as a single unit, and the procedure was stopped.There was a clinically significant delay in the procedure.Reportedly, the patient experienced a stroke and was transferred to the intensive care unit (icu).The patient remains hospitalized in renal failure.The distal lesion was never treated.It is unknown what, if any treatment was provided for the stroke or renal failure.No additional information was provided.
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(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The reported patient effects of cerebrovascular accident (stroke) and renal failure are known observed and potential patient effects as listed in the xience v and xience nano everolimus eluting coronary stent system electronic instructions for use.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the electronic complaint database revealed no other similar incidents reported for difficult to position (crossability) from this lot.Based on the reviewed information, no product deficiency was identified.
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