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 from this lot.Potential causes for activation/deployment failure include, but are not limited to, manufacturing, anatomical conditions; deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens/ratchet), or inadequate pre-dilatation of the stricture.Additionally, potential factors that may contribute to stent fractures include, but are not limited to, processing and/or handling in manufacturing, handling during preparation for use, lesion characteristics, procedural technique, product size selection, severe torqueing or kinking of stent (material stress/ fatigue), interaction with the accessory devices, lesion and/or anatomy.Fatigue from artery dynamics (pulsatile flow) and motion may also contribute to stent fractures during or after the procedure.It is possible that interaction with the tortuous anatomy resulted in the reported activation/deployment failure; however this cannot be confirmed.The treatment appears to be related to the operational context of the procedure as an additional balloon was used to further deploy the stent and implant it in the vessel.In addition, it is possible that over post-dilation of the stent resulted in the reported material separation/stent break; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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