Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were able to be confirmed.The reported material separation was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent deviation of the instructions for use (ifu) as it is likely that during advancement onto the guide wire interaction of devices possibly due to procedural contaminants (blood, contrast) resulted in the noted bunched inner member; thus resulting in the reported difficulty to advance and the reported difficulty to remove.It should be noted that the xience sierra everolimus eluting coronary stent system instructions for use (ifu) states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Manipulation of the device using force resulted in the noted device damages (stretched inner/outer member, bunched balloon) and ultimately resulted in the reported material separation/noted inner and outer member separations.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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