(b)(4).Evaluation summary: the device was returned for analysis.The reported collapse tip was unable to be confirmed; however, the stent was noted to be dislocated on the balloon.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.Due to the extent of the damage to the stent, it is unlikely that the protective sheath would have fit over the damage; therefore, the damage is not a pre-existing condition.It is likely that the reported tip collapse and noted stent dislocation was a result of inadvertent mishandling of the sds during unpackaging and/or during preparation and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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