The valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received form the clinical study investigation site: ¿pi (principal investigator) confirmed that it was not possible that the pneumothorax was caused by the certas.To clarify: according to the pi this ae is not causal related to the device.It may be related to the procedure.The pi will check the patient files and look into other details of the ae including medication and resolution.¿.
|