It was reported that after a left transcaphoid artery revascularization (tcar) procedure, the patient experienced baroreceptor dysfunction.The patient remained an inpatient for three days post procedure and was given norepinephrine until the baroreceptors normalized.It is unknown if the enroute transcaphoid stent system (tss) contributed to baroreceptor dysfunction and therefore, this report will be reported out of an abundance of caution.
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The product associated with this 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 led to the adverse event reported.There is no indication that a malfunction of the srm device occurred.It is unknown if the enroute transcaphoid stent system (tss) contributed to baroreceptor dysfunction and therefore, this report will be reported out of an abundance of caution.Complaints will continue to be reviewed and monitored for trends.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.
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