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 incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.Report indicates a 6mm diameter left popliteal artery that was predilated with a 6.00x120mm balloon for 2 minutes at 10 atmospheres of pressure through a 6fr x55cm sheath over a command st guide wire.6.0 x 60mm was advanced to target lesion without issue.Report indicates difficulty deploying as the physician advanced the thumb-slide until the stent eventually deployed without issue.Under fluoroscopy, the report states the physician confirmed fully opposed stent and delivery system removed intact.No adverse patient effect and no significant delay noted.An attached link to a screen capture video was included in the complaint showing most of the stent deployed distally in the popliteal artery.As the delivery system is retracted back to uncover the rest of the stent and the thumb-slide is advanced, it does appear to ¿stall¿ or be delayed as the operator continues to manipulate the stent delivery system until the operator eventually was able to release the stent fully opposed to vessel wall confirmed via fluoroscopy.With the media submitted, information provided from the complaint confirming a reasonable approach to pretreat the lesion and reasonable equipment used, there does appear to be an issue with the device.While the device did deliver the stent to the intended target lesion fully opposed, there is evidence that the device did malfunction as there was a delay/difficulty in deploying the stent.The reason for malfunction of the device cannot be determined.Potential causes for activation 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.It is possible that during stent deployment interaction with the anatomy and/or other devices resulted in the ratchet being unable to properly engage/fully deploy the stent; thus, resulting in reported difficult or delayed activation; 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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