It was reported that the procedure was to treat a heavily tortuous, moderately calcified left anterior descending artery (lad) with a previous coronary artery bypass graft using the mammary artery.The 3.5x18mm xience sierra stent delivery system (sds) was advanced and met resistance with anatomy; however, the sds was re-inserted and resistance was noted with the use of an unspecified microcatheter and anatomy during advancement and withdrawal.The sds shaft separated in the microcatheter.All the separated portions were removed with the removal of the microcatheter.Another non-abbott stent and new microcatheter were used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.No additional information was reported.
|
A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance and difficult to remove could not be tested due to the condition of the returned device.The reported difficult to advance (anatomy) could not be tested as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that the sds was inserted into the anatomy, removed, and then reinserted back into the anatomy.It should be noted that the xience sierra instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.In this case, it is unknown if the ifu deviation contributed to the reported event the investigation determined the reported difficulties are related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|