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Additional details were received from the clinical events committee (cec) meeting minutes that as the angioguard rx ecgw was deployed, the patient developed the severe spasms in the right ica just proximal and distal to the filter placement.At some point, the procedure was complicated by transient weakness in the left upper extremity, as well as with transient hypotension.The angioguard¿ rx ecgw was removed with minimal debris found in the filter.Ntg was administered intracerebrally into the right ica and ¿all spasms improved dramatically.¿ after bringing the blood pressure up with neosynephrine and fluids and ia ntg administration, relieving the spasms, the left upper extremity recovered completely and the patient was neurologically intact and at baseline at the end of procedure.Final intracerebral angiography revealed no obvious pathology.Additional medical history included: dyslipidemia.The ecrf reported contralateral carotid occlusion, however, per catheterization report; there was mild disease on the left.Additional lab results/tests provided: a brain ct scan on (b)(6) 2013 showed no acute abnormality.(b)(4).Complaint conclusion: as reported by the (b)(4) study, a patient experienced a sudden onset of left sided weakness and left hand paresis that was diagnosed as transient ischemic attack (tia) after post-dilation of a stent.The patient was treated with the use of an aspiration catheter.The patient also had hypotension that was treated with a neosynephrine bolus and fluids, and a vessel spasm that was treated with nitroglycerine (ntg).The patient also had a brief asystole that resolved without treatment.The patient fully recovered from the event with no residual deficits and was discharged the next day.The patient is a (b)(6) male with a medical history of hyperlipidemia, abnormal stress test, and coronary artery disease.The ecrf reported a contralateral carotid occlusion, however, per catheterization report; there was mild disease on the left.The target lesion was located in the ostium of the right internal carotid artery with a length of 20mm and a diameter of 8mm.The lesion was eccentric and ulcerated with 99% stenosis.The vessel was a type i arch vessel with mild tortuosity.The patient also had an occlusion in the contralateral carotid.The nih and rankin stroke scale scores were both 0 at baseline and the patient was symptomatic before the procedure.The patient had complaints of being dizzy and off balance that came and went and has been happening for months.The pre-procedure blood pressure was 194/81.An 8 mm medium support angioguard rx embolic protection device was successfully deployed past the lesion.As the angioguard was deployed, the patient developed severe spasms in the vessel just proximal and distal to the filter placement.Pre-dilation was performed.Then, a 9x30mm precise pro rx stent was successfully deployed at the target lesion and post-dilation was performed with a 6x30mm aviator plus pta catheter, leaving a final stenosis rate of 0%.After post dilation of the stent, the blood pressure was 129/49, and the patient had brief asystole that resolved without treatment.After post-dilation, the patient experienced a sudden onset of left side weakness, transient left hand paresis and transient hypotension.The patient was treated with 50mcg neosynephrine bolus for 3 doses and fluids for the hypotension; and an aspiration catheter was used x 75ml with a small amount of debris.Then, the angioguard was retrieved and a small amount of debris was found in the filter.Ntg was administered intracerebrally into the right ica and ¿all spasms improved dramatically.¿ after the bringing the blood pressure back up and relieving the spasms, the left upper extremity recovered completely and the patient was neurologically intact.The total event lasted approximately 5 minutes with no further symptoms from the time of the event.The final blood pressure provided was 118/62.There was no documented dissection or presence of air bubbles.Final intracerebral angiography revealed no obvious pathology.There was no neurological deficit when patient left the angiography suite.The patient recovered fully with no residual deficits.The physician believes that the event was related to the index procedure.A brain ct scan was performed later that day and showed no acute abnormality.The patient was discharged next day with an nih and rankin score of 0.At the 30-day follow-up, the nih and rankin score were 0 with no adverse event reported.The device remains implanted; therefore, it is not available for analysis.A device history record (dhr) review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15659208 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.A tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such.Tia is often associated with a temporary stoppage or slowing of blood flow to the cerebral arteries.The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may collect in the embolic protection device or flow downstream potentially disrupting perfusion both during and after carotid stent implantation.By definition ((b)(6)), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes.Tia occurs when the blood supply to part of the brain is briefly interrupted.Tia symptoms are similar to those of stroke but do not last as long.Most symptoms of a tia disappear within an hour.The hemodynamic instability that occurs both during and after carotid stent implantation is influenced by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds (stent delivery system) and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This could result in a fall in blood pressure (hypotension) and a drop in heart rate.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events associated with the compression of the baro-receptors during balloon inflation, stent implantation and filter device manipulation.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.In this case, the patient experienced an asystole, which is the absence of heartbeat.However, this event was brief and resolved without treatment.This may have occurred due to the stretch of the baro-receptors.A vessel spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and is listed in the ifu (instructions for use) as such.Review of the available information suggests that patient factors, vessel/lesion characteristics and/or procedural factors may have contributed to the event.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported event does not appear to be related to the manufacturing process.
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Additional information was reported that post-dilation was performed with a 6x30mm aviator plus pta catheter.The tia occurred after post-dilation of the stent.The product remains implanted and is thus not available for analysis.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted 30 days upon receipt.Additional information has been reported for concomitant devices from that the lot # for the 8mm angioguard used is 70713451.Also, the unknown balloon catheter used for post-dilation is a 6x30mm aviator plus, lot 15984685, catalog 4246030w.Please note that an additional product has been reported as associated with this adverse event.Therefore, an additional associated report number is provided to this complaint.This is one of three products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00073, 1016427-2014-00015 and 9616099-2014-00128.
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As reported by the (b)(4) study, a patient experienced sudden onset of left sided weakness and left hand paresis that was diagnosed as transient ischemic attack (tia) during the procedure.The patient was treated with neosynephrine bolus, and the use of an aspiration catheter.The patient also had a brief asystole that resolved without treatment.There was a severe vessel spasm proximal and distal to the angioguard that was treated with nitroglycerine.The patient fully recovered from the event with no residual deficits and was discharged the next day.The target lesion was located in the ostium of the right internal carotid artery with a length of 20mm and a diameter of 8mm.The lesion was eccentric and ulcerated with 99% stenosis.The vessel was a type i arch vessel with mild tortuosity.The patient also had an occlusion in the contralateral carotid.The nih and rankin stroke scale scores were both 0 at baseline and the patient was symptomatic before the procedure.The patient had complaints of being dizzy and off balance that comes and goes and has been happening for months.The pre-procedure blood pressure was 194/81.An 8 mm medium support angioguard rx embolic protection device was successfully deployed past the lesion, and pre-dilatation was performed.Then, a 9x30mm precise pro rx stent was successfully deployed at the target lesion and post-dilation was performed, leaving a final stenosis rate of 0%.After post dilation of the stent, the blood pressure was 129/49, and the patient had brief asystole that resolved without treatment.There was also a severe spasm proximal and distal to the angioguard, and nitroglycerin 100 mcg was given as treatment.Sometime during the procedure, the patient experienced a sudden onset of left side weakness and transient left hand paresis.The patient was treated with 50mcg neosynephrine bolus for 3 doses and an aspiration catheter was used x 75ml with a small amount of debris.
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Cont of describe event or problem:then, the angioguard was retrieved and a small amount of debris was found in the filter.The total event lasted approximately 5 minutes with no further symptoms from the time of the event.The final blood pressure provided was 118/62.There was no documented dissection or presence of air bubbles.There was no neurological deficit when patient left the angiography suite.The patient recovered fully with no residual deficits.The physician believes that the event was related to the index procedure.The patient was discharged next day with an nih and rankin score of 0.At the 30-day follow-up, the nih and rankin score were 0 with no adverse event reported.The product remains implanted and is thus not available for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.Concomitant medications: heparin, neosynephrine and nitroglycerine were given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Concomitant devices : 8mm angioguard rx catalog number 801814rmc, and an unknown balloon catheter used for post-dilation.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00073 and 1016427-2014-00015.
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