| Catalog Number PC0940RXC |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)
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| Event Date 12/23/2013 |
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Event Type
Injury
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Event Description
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As reported by the sapphire registry, a patient had a sudden onset of transient right sided weakness and nominal aphasia during the removal of a 7mm angioguard after a 9x40mm precise pro rx stent was implanted.The event was later determined as a transient ischemic attack (tia).The tia was treated with a heparin drip and plavix therapy, and the patient was transferred to the cicu.After treatment, the patient¿s symptoms improved, yet there were still deficits.The patient was expected to be discharged 5 days after the event, and had an nih score of 5 and a rankin score of 4.The target lesion was located in the left proximal internal carotid artery, with a length of 25mm and a diameter of 6.5mm.The concentric lesion was contoured and ulcerated, and it was mildly calcified with 80% stenosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was symptomatic before the procedure.During the procedure, a 7mm angioguard rx embolic protection device was inserted into the patient and deployed past the lesion before pre-dilation was performed.Then, a 9x40mm precise pro rx stent was deployed at the target lesion, leaving a final stenosis rate of 10%.After that, the 7mm angioguard was removed, and found to have a large amount of debris in the basket.There was none documented presence of air bubbles.However, during removal of the angioguard, the patient had a sudden onset of transient right sided weakness and nominal aphasia which resolved later in the day.The patient was unable to say wife¿s name or the year, his right hand drip was weaker than the left hand, he had a slight droop on the right when he smiled and his thought process was a little slow.The patient was treated with a heparin drip and plavix therapy, and the patient was transferred to the cicu.
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Manufacturer Narrative
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The patient was also reported to have an altered loss of consciousness and confusion, which was found to be related to icu psychosis by the doctor.The patient¿s symptoms improved with treatment, and the patient was transferred back to the floor.However, the patient still has a residual deficit of arm weakness.The patient was expected to be discharged 5 days after the event, and has an nih score of 5 and a rankin score of 4.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 within 30 days upon receipt.Concomitant medications: heparin and plavix were given during the procedure and post-procedure.Concomitant devices: 7mm angioguard rx, catalog number 701814rmc, lot number 70713522.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00035 and 1016427-2014-00006.
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Manufacturer Narrative
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Adjudication minutes were received and reviewed.The cec agreed that a cva- major, ipsilateral, ischemic/embolic occurred and was device and procedure-related.Additional details were received from the clinical events committee (cec) meeting minutes: during the procedure, the patient developed sudden onset of neurological deficits: right-sided weakness and nominal aphasia.Post-procedure, the patient continued to have right-sided weakness and some intermitted confusion.Neurological evaluation on (b)(6) 2013 at 13:50 noted right upper extremity weakness; no other focal deficits were reported at that time.Impression: concern for acute cva with positive clinical changes including mild right-sided weakness and mild intermittent confusion.On (b)(6) 2013, the nih stroke scale score was 5 and the rankin stroke scale score was 4.Neurology consultation on (b)(6) 2013 was performed for confusion, agitation.Review of the system was unable to be obtained due to altered mentation.The patient was not oriented to person, place, or situation, not answering questions appropriately.Muscle strength of lower extremities was intact bilaterally.Unable to determine right upper extremity.Possibly a small right mouth droop.Unable to do neurological examination secondary to altered mentation.Assessment: 1) acute encephalopathy, suspect, likely to acute stroke, possible exacerbated by lorazepam.The patient was placed in restraints.Medication adjustment with administration of p.R.N.Zyprexa and discontinuation of ativan and bendryl was recommended.2) acute stroke, likely embolic, reasonable to repeat ct scan when the patient could tolerate the test.Zyprexa was reported to be effective, and confusion resolved in 24-36 hours.The patient was discharged on (b)(6) 2013 on asa and clopidogrel.His discharged on asa and clopidogrel.Additional lab results/tests provided: a brain ct scan on (b)(6) 2013 revealed the following, according to radiology report impression: stable appearance of the brain with an area of prior ischemia or infarct in the left posterior frontal region near the vertex (similar to previous study on (b)(6) 2013 and may be an area of prior ischemia, per finding description).A follow-up ct scan on (b)(6) 2013 reported no acute intracranial hemorrhage or mass effect, noting old left parietal infarct.Duplex ultrasound on (b)(6) 2013 reported patent study stent with normal velocities.Echocardiography on (b)(6) 2013 revealed ef of 55-60% without wall motion abnormalities.Additional medications were provided: lorazepam, zyprexa, asa.(b)(4).Additional information is pending and will be submitted within 30-day upon receipt.This is one of two products involved with the reported adverse events and the associated manufacturer report numbers are 9616099-2014-00035 and 1016427-2014-00006.
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Manufacturer Narrative
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Additional information was received that the patient was symptomatic before the procedure due to a stroke earlier in the year.The treatment of the tia with heparin is standard of care for a patient with a tia.Following stent procedure, the patient developed hypotension and required vasopressor therapy for approximately 24 hours.The patient was given phenylephrine hcl.Subject was weaned off the vasopressors and eventually restarted his lisinopril.Blood pressure stable at discharge.After the doctor reassessed this subject¿s post carotid stent adverse events.He changed the tia to ¿possibly related to device and procedure¿, the icu psychosis as ¿not related to device or procedure¿, and the hypotension as ¿not related to device, possibly related to procedure¿.The patient was discharged 5 days after the event in stable condition to home.Additional concomitant medications : phenylephrine hcl was given after procedure.Lisinopril was given before the procedure and after vasopressor therapy with phenylephrine hcl was completed.Aspirin and clopidorgrel were given pre and post procedure.Bivalrudin was given during the procedure.Previous stroke earlier in the year.(b)(4).This is one of two products involved with the reported adverse events and the associated manufacturer report numbers are 9616099-2014-00035 and 1016427-2014-00006.Complaint conclusion: as reported by the sapphire registry, a patient had a sudden onset of transient right sided weakness and nominal aphasia during the removal of a 7mm angioguard after a 9x40mm precise pro rx stent was implanted.The event was later determined as a transient ischemic attack (tia).The tia was treated with a heparin drip and plavix therapy, and the patient was transferred to the cicu.After treatment, the patient¿s symptoms improved, yet there were still deficits.Following stent procedure, the patient developed hypotension and required vasopressor therapy for approximately 24 hours to stabilize blood pressure.The patient was discharged 5 days after the event in stable condition to home.The patient is a (b)(6) - year-old male with a medical history of a previous stroke, hyperlipidemia, hypertension, cabg, coronary artery disease, previous mi and history of smoking.The target lesion was located in the left proximal internal carotid artery, with a length of 25mm and a diameter of 6.5mm.The concentric lesion was contoured and ulcerated, and it was mildly calcified with 80% stenosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale scores were both 0 at baseline.The patient was symptomatic before the procedure due to a stroke earlier in the year.During the procedure, a 7mm angioguard rx embolic protection device was inserted into the patient and deployed past the lesion before pre-dilation was performed.Then, a 9x40mm precise pro rx stent was deployed at the target lesion, leaving a final stenosis rate of 10%.After that, the 7mm angioguard was removed, and found to have a large amount of debris in the basket.There was none documented presence of air bubbles.However, during removal of the angioguard, the patient had a sudden onset of transient right sided weakness and nominal aphasia which resolved later in the day.The patient was unable to say wife¿s name or the year, his right hand drip was weaker than the left hand, he had a slight droop on the right when he smiled and his thought process was a little slow.A ct of the head reported ¿[s]table appearance of the brain with an area of prior ischemia or infarct in the left posterior frontal region near the vertex (similar to previous study 10/20/13 and maybe be an area of prior ischemia).The patient was treated with a heparin drip and plavix therapy, and the patient was transferred to the cicu.The treatment of the tia with heparin is standard of care for a patient with a tia.The patient was also reported to have an altered loss of consciousness and confusion, which was found to be related to icu psychosis by the doctor.The patient¿s symptoms improved with treatment, and the patient was transferred back to the floor.However, the patient still has a residual deficit of arm weakness.A ct of the head two days after the event reported ¿[n]o acute intracranial hemorrhage or mass effect.Old left parietal infarct.¿ following stent procedure, the patient also developed hypotension and required vasopressor therapy for approximately 24 hours.The patient was given phenylephrine hcl.Subject was weaned off the vasopressors and eventually restarted his lisinopril.The patient was discharged 5 days after the event in stable condition to home.Blood pressure was stable at discharge.Patient had an nih score of 5 and a rankin score of 4.The device was implanted; and therefore 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 15958878 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Hypotension and the resultant tia are well-known potential adverse events associated with the carotid stent implantation procedure.Tia symptoms are similar to those of stroke but do not last as long.Typically symptoms of a tia often last only a few minutes, most symptoms resolve within an hour but they may last up to 24 hours.A tia occurs when the blood supply to part of the brain is briefly interrupted.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 results in a fall in blood pressure and bradycardia.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.Icu psychosis is a disorder in which patients in an intensive care unit (icu) or a similar setting experience a cluster of serious psychiatric symptoms.Icu psychosis is a form of delirium, or acute brain failure.Many factors can be involved in causing icu psychosis, such as lack of orientation, stress, medical monitoring, critical illness, and medications.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.Neither the dhr nor the information available for review indicate that there is a design or manufacturing related issue, therefore no corrective action is required.
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Manufacturer Narrative
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Updated complaint conclusion based on the adjudication minutes: as reported by the sapphire registry, the patient is a (b)(6) male with a medical history of a previous stroke, hyperlipidemia, hypertension, cabg, coronary artery disease, previous mi and history of smoking.The target lesion was located in the left proximal internal carotid artery, with a length of 25mm and a diameter of 6.5mm.The concentric lesion was contoured and ulcerated, and it was mildly calcified with 80% stenosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale scores were both 0 at baseline.The patient was symptomatic before the procedure due to a stroke earlier in the year.During the procedure, a 7mm angioguard rx embolic protection device was inserted into the patient and deployed past the lesion before pre-dilation was performed.Then, a 9x40mm precise pro rx stent was deployed at the target lesion, leaving a final stenosis rate of 10%.After that, the 7mm angioguard was removed, and found to have a large amount of debris in the basket.There was none documented presence of air bubbles.However, during removal of the angioguard, the patient had a sudden onset of right sided weakness and nominal aphasia.The patient was unable to say wife¿s name or the year, his right hand drip was weaker than the left hand, he had a slight droop on the right when he smiled and his thought process was a little slow.Post-procedure, the patient continued to have right-sided weakness and some intermitted confusion.Neurology consult impression: ¿concern for acute cva with positive clinical changes including mild right-sided weakness and mild intermittent confusion.¿ a ct of the head reported ¿[s]table appearance of the brain with an area of prior ischemia or infarct in the left posterior frontal region near the vertex (similar to previous study (b)(6) 2013 and maybe be an area of prior ischemia).The patient was treated with a heparin drip and plavix therapy, and the patient was transferred to the cicu.The patient was also reported to have an altered loss of consciousness and confusion, which was found to be related to icu psychosis by the doctor.The patient had acute encephalopathy, suspect, likely to acute stroke, possible exacerbated by lorazepam.The patient was placed in restraints.Medication adjustment with administration of prn zyprexa and discontinuation of ativan and benadryl was recommended.The patient was diagnosed with an acute stroke, likely embolic.Zyprexa was reported to be effective, and confusion resolved in 24-36 hours.The patient¿s symptoms improved with treatment, and the patient was transferred back to the floor.However, the patient still has a residual deficit of arm weakness.A ct of the head two days after the event reported ¿[n]o acute intracranial hemorrhage or mass effect.Old left parietal infarct.¿ duplex ultrasound on (b)(6) 2013 reported patent study stent with normal velocities.Echocardiography on (b)(6) 2013 revealed ef of 55-60% without wall motion abnormalities.Following stent procedure, the patient also developed hypotension and required vasopressor therapy for approximately 24 hours.The patient was given phenylephrine hcl.Subject was weaned off the vasopressors and eventually restarted his lisinopril.The patient was discharged 5 days after the event in stable condition to home.Blood pressure was stable at discharge.Patient had an nih score of 5 and a rankin score of 4.The device was implanted; and therefore 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 15958878 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.A cerebrovascular accident (cva) is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.This act, inherent to the procedure may have contributed to the reported event.A blood vessel that is not blocked, but is extremely narrowed, can also cause an ischemic stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.During a cva, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells.Early medical intervention can halt this process and reduce the risk for irreversible complications.Hypotension is a well-known potential adverse events associated with the carotid stent implantation procedure.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 and bradycardia.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.Icu psychosis is a disorder in which patients in an intensive care unit (icu) or a similar setting experience a cluster of serious psychiatric symptoms.Icu psychosis is a form of delirium, or acute brain failure.Many factors can be involved in causing icu psychosis, such as lack of orientation, stress, medical monitoring, critical illness, and medications.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.Neither the dhr nor the information available for review indicate that there is a design or manufacturing related issue, therefore no corrective action is required.
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