The product was not returned to abbott vascular 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 and/or complaints reported from this lot.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.It is likely that manipulation during advancement or back and forth movement during advancement likely caused the stent dislodgement against the guiding catheter or other devices used in the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the procedure was performed to treat a lesion in the heavily calcified renal artery.The herculink elite stent system was advanced through the unspecified guide catheter and it was noted that the stent dislodged, remaining in the guide catheter.There was no resistance noted during advancement.As the stent remained in the guide catheter, the devices were removed as a single unit, without difficulty, and the stent remained in the guide catheter.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
|