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 similar incidents from this lot.It is possible that interaction with the anatomy resulted in the reported stent dislodgement; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The reported foreign body in patient and attempted treatment appears to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a moderately calcified, moderately tortuous lesion in the left anterior descending (lad) artery.A 3x18mm xience sierra drug eluting stent (des) was advanced to the target lesion without issue.During deployment, the stent came off the balloon and migrated into the patient's arm.An attempt was made to snare the stent, however it migrated again into the patient's hand.The stent became embedded in the ulnar artery where it remains with no further attempts to remove.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.
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