The device was not returned for analysis.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 reported from this lot.The investigation was unable to determine a conclusive cause for the reported stent break.It is possible that inadvertent mishandling while unpackaging the device resulted in the noted ¿fracture¿ of the device; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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