(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of allergic reaction is listed in the otw omnilink elite instructions for use as a known potential complication associated with the use of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the procedure was performed on (b)(6) 2018 to treat a lesion in the superior mesenteric artery.A 6.0mmx19mmx80cm omni elite stent was implanted without issue.The patient was started on plavix on (b)(6) 2018.Two or three weeks after the procedure (date unknown), the patient developed a rash, itching and hives throughout the body.The patient saw her primary doctor and the patient was given prednisone and hydroxyzine.The physician informed the patient the reaction she is having does not appear to be related to an antibiotic she is taking for dental treatment performed after the stent implant procedure.The patient was taking the antibiotic from (b)(6) to (b)(6).The patient will see an allergist and dermatologist this week.No additional information was provided.
|