(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Device codes: 2017 labeled.Internal file number - (b)(4).Correction - reg#.Device code 2017 added: failure to follow steps.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It should be noted that the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use, states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the ifu deviation contributed to the reported event.Additionally, the ifu states: deflate the balloon by pulling negative on the inflation device for 30 seconds.Confirm complete balloon deflation before attempting to move the delivery system.It is likely the ifu deviation contributed to the reported deflation issue.The investigation determined the reported deflation issue appears to be related to the use error, as it was reported and confirmed during follow up with the account that negative pressure was held for 20 seconds in order to deflate the balloon.In addition, there was no damage noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.Further interaction with the moderately tortuous, heavily calcified, 80% stenosed lesion during advancement, as resistance was noted, likely resulted in the reported physical resistance.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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