(b)(4).Evaluation summary: visual inspections were performed on the returned device.The stent dislodgement was 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 identified no other similar incidents from this lot.The investigation determined it is likely that inadvertent user mishandling during preparation contributed to the dislodgement.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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