(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that on (b)(6) 2017, the procedure was to treat a heavily calcified lesion in the proximal circumflex (cx) coronary artery.After pre-dilating the lesion a 2.5 x 23 mm rx xience alpine stent delivery system (sds) was advanced, but the sds failed to cross due to a difficult vessel turn and heavy calcification at the ostial cx, prior to reaching the lesion.Force was applied and the stent dislodged at the left main (lm) to proximal cx area.After removing all devices as a single unit, the dislodged stent was able to be pulled back to the left main using a snare device, but was unable to be retrieved.The dislodged stent was then crushed against the vessel wall of the lm and cx ostium using a balloon, followed by deployment of an additional unspecified stent to secure the crushed stent.Treatment of the target lesion was abandoned with future plans for treatment, and the patient was transferred in stable condition to the intensive care unit (icu) for observation as a precaution.There were no adverse patient sequelae.As of (b)(6) 2017, the patient was doing well and due to be discharged the following day.No additional information was provided.
|