The product in complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.On 17dec2019 silk road medical contacted osb to inform them of medical device reports that were not reported within the mandatory reporting timeframe.It is noted here, per fda's request, that this mdr was identified as part of a complaint handling remediation effort associated with capa-(b)(4).
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It was reported that a patient underwent a transcarotid (tcar) procedure on (b)(6) 2018.Initially after the anesthesia had worn off, a neuro exam revealed movement in all extremities.The physician reported that the patient suffered a significant stroke post-procedure, which affected the patient's speech, left-sided movement and swallowing.The patient was slow to wake up after the initial neuro exam.No additional details were provided.
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