| Catalog Number PC0830RXC |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Cardiac Arrest (1762); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)
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| Event Date 02/17/2014 |
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Event Type
Injury
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Event Description
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As reported by the (b)(4) study, a patient had a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness during/right after post-dilation of an 8x30mm precise pro rx stent with a non-cordis balloon while the angioguard rx was in place past the lesion.The patient was diagnosed with a transient ischemic attack (tia).The patient was treated and partially recovered with minor residual deficits of mild right facial droop.The patient was discharged two days after the event/procedure.The target lesion was located in the left proximal internal carotid artery with a length of 20mm and a diameter of 8mm.The eccentric lesion was severely calcified in a concentric and circumferential manner with the width greater than or equal to 3mm.The stenosis rate was 99% and there was no lesion thrombosis.The vessel was a type i arch vessel with moderate tortuosity and two or more bends.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was symptomatic before the procedure with transient left eye blindness.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was deployed at the target lesion before the stent was post-dilated with a 5x20mm non-cordis balloon catheter, leaving a final stenosis rate of 10%.During/after post-dilation of the stent, the patient began to suffer from a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness.The patient was later diagnosed with a tia.The patient was given was given atropine and phenylephrine, and the patient responded well to the treatment.The angioguard was successfully retrieved and found to have debris in the basket.There was none documented presence of air bubbles and the patient had a neurological deficit when leaving the angiography suite.
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Manufacturer Narrative
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No ct/mri of the head was performed.The patient partially recovered with minor residual deficits of right mild facial droop.The patient was discharged two days after the event/procedure with an nih score of 1 and a rankin score of 0.The patient is currently doing fine.This device remains implanted; therefore, it is 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, atropine, and phenylephrine was given during the procedure.Pre and post-procedure medications included clopidogrel.Concomitant devices: 7mm angioguard rx, catalog # 701814rmc, lot # 70613416; and a 5 x 20 mm sterling balloon.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.
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Manufacturer Narrative
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Additional information was provided: facial paralysis was on the right side and it was a continuation of the neurological even that started on (b)(6) 2014.It was also reported that an unknown neurological adverse event occurred about a month after the cva that was post-adjudicated as no event.Additional information is pending and will be submitted within 30 days upon receipt.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.
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Manufacturer Narrative
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Additional information: at the 30-day follow-up, the patient had an nih score of 1 and a rankin score of 0.No adverse event occurred after discharge.Please note that the weight of the patient has been changed to (b)(6).This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.Complaint conclusion: as reported by the sapphire study, a patient had a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness during/right after post-dilation of an 8x30mm precise pro rx stent with a non-cordis balloon while the angioguard rx was in place past the lesion.The patient was diagnosed with a transient ischemic attack (tia).The patient was treated and partially recovered with minor residual deficits of mild right facial droop.The patient was discharged two days after the event/procedure.The patient was a (b)(6) male with a medical history of hyperlipidemia and cabg, history of tia, prior right carotid endarterectomy and abnormal stress test.The target lesion was located in the left proximal internal carotid artery with a length of 20mm and a diameter of 8mm.The eccentric lesion was severely calcified in a concentric and circumferential manner with the width greater than or equal to 3mm.The stenosis rate was 99% and there was no lesion thrombosis.The vessel was a type i arch vessel with moderate tortuosity and two or more bends.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was symptomatic before the procedure with transient left eye blindness.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was deployed at the target lesion before the stent was post-dilated with a 5x20mm non-cordis balloon catheter, leaving a final stenosis rate of 10%.During/after post-dilation of the stent, the patient began to suffer from a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness.The patient was later diagnosed with a tia.The patient was given was given atropine and phenylephrine, and the patient responded well to the treatment.The angioguard was successfully retrieved and found to have debris in the basket.There was none documented presence of air bubbles and the patient had a neurological deficit when leaving the angiography suite.No ct/mri of the head was performed.The patient partially recovered with minor residual deficits of right mild facial droop.The patient was discharged two days after the event/procedure with an nih score of 1 and a rankin score of 0.At the 30-day follow-up, the patient had an nih score of 1 and a rankin score of 0.No adverse event occurred after discharge.The patient is currently doing fine.The device remains implanted; therefore, it was 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 15860659 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.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.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.There is no evidence to suggest that the event is related to the design or manufacturing process of the device.Review of the available information suggests that patient factors and/or vessel/lesion characteristics 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 failure/event does not appear to be related to the manufacturing process.
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Manufacturer Narrative
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Adjudication minutes were received.The cec (clinical events committee) agreed that a cva-minor, ipsilateral, ischemic/embolic occurred and was procedure and device-related.Additional information was received from the adjudication minutes: the catheterization summary reported that post-stent dilation the patient had a period of asystole of 10 seconds and was immediately given atropine and neo-synephrine.He became less responsive, had a right facial droop, and was unable to speak.Subsequent angiogram showed good flow with normal cerebral flow, improved when compared to prior image in the system.Over the next 15 minutes with iv neo-synephrine, with improvement in blood pressure, he had significant improvement in his neurological status.He was able to complete a near full smile, follow commands, squeeze his right hand and move right foot, able to speak with mild difficulty - no issues with word finding or movement.The patient did have some mild hypotension (80-90 mmhg systolic blood pressure) for which he required a 0.4 mcg drip of neo-synephrine that was anticipated titrating off over the next 12 hours.Post-procedure, the nih stroke scale score was 1 due to right ¿very slight¿ facial droop.The rankin stroke scale score was 0.The patient was admitted to icu later that day.Neurocritical care unit daily progress report noted that nih stroke scale score was 1 the day after the procedure.Neurological examination revealed: a&ox4, calm, appropriate, face symmetric; speech: ¿names/repeats, subjective dysarthric¿; motor bue and ble 5/5; sensory and coordination intact.Assessment and plan: aphasia and hemiparesis s/p lt cas and post-stent plasty, history of cva x3 with residual left hemiparesis; history of right cea; neurological exam improved; to continue clopidogrel; to consider coumadin after sheath removed and hemostasis achieved; to maintain systolic blood pressure at 150-160 mmhg for optimal cerebral perfusion.Subsequently the patient had slurred speech, blurred vision and left-sided hemiparesis.These symptoms resolved almost completely by discharge.Post-intervention most of his blood pressure medications were held to ensure adequate cerebral perfusion.He was maintained on asa, clopidogrel and statins.Cva: post-procedural aphasia and hemiparesis; evaluated by neurology team and initial recommendations were to hold his cardura, metoprolol and norvasc so the blood pressure could be maintained 150-160 mmhg range; coumadin was resumed per his prior home dose.He was advised to continue with pt if needed.Additional medications: cardura, metoprolol, and norvasc.Additional medical history: the patient has a medical history of two cabg surgeries in 1992 and 1998, stage iv ckd, chronic anticoagulation, diabetes, aaa, repeat left renal artery angioplasty with stent placement, and repeat celiac axis angioplasty with stent placement, three strokes with ¿mild residual left-sided weakness¿, and left carotid /left subclavian artery bypass.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.
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Manufacturer Narrative
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This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.Complaint conclusion updated with additional information: as reported by the (b)(4) study, the patient was a (b)(6) male with a medical history of two cabg surgeries in 1992 and 1998, hyperlipidemia, history of tia, prior right carotid endarterectomy, abnormal stress test, stage iv ckd, chronic anticoagulation, diabetes, aaa, repeat left renal artery angioplasty with stent placement, and repeat celiac axis angioplasty with stent placement, three strokes with ¿mild residual left-sided weakness¿, and left carotid /left subclavian artery bypass.The target lesion was located in the left proximal internal carotid artery with a length of 20mm and a diameter of 8mm.The eccentric lesion was severely calcified in a concentric and circumferential manner with the width greater than or equal to 3mm.The stenosis rate was 99% and there was no lesion thrombosis.The vessel was a type i arch vessel with moderate tortuosity and two or more bends.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was symptomatic before the procedure with transient left eye blindness.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was deployed at the target lesion before the stent was post-dilated with a 5x20mm non-cordis balloon catheter, leaving a final stenosis rate of 10%.The catheterization summary reported that post-stent dilation the patient had a period of asystole of 10 seconds and was immediately given atropine and neo-synephrine.During/after post-dilation of the stent, the patient began to suffer from a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness.He became less responsive, had a right facial droop, and was unable to speak.Subsequent angiogram showed good flow with normal cerebral flow, improved when compared to prior image in the system.Over the next 15 minutes with iv neo-synephrine, with improvement in blood pressure, he had significant improvement in his neurological status.He was able to complete a near full smile, follow commands, squeeze his right hand and move right foot, able to speak with mild difficulty - no issues with word finding or movement.The patient did have some mild hypotension (80-90 mmhg systolic blood pressure) for which he required a 0.4 mcg drip of neo-synephrine that was anticipated titrating off over the next 12 hours.The angioguard was successfully retrieved and found to have debris in the basket.There was none documented presence of air bubbles and the patient had a neurological deficit when leaving the angiography suite.Post-procedure, the nih stroke scale score was 1 due to right ¿very slight¿ facial droop.The rankin stroke scale score was 0.The patient was admitted to icu later that day.No ct/mri of the head was performed.The patient partially recovered with minor residual deficits of right mild facial droop.Post-intervention most of his blood pressure medications were held to ensure adequate cerebral perfusion.The patient was discharged two days after the event/procedure with an nih score of 1 and a rankin score of 0.Cva: post-procedural aphasia and hemiparesis; evaluated by neurology team and initial recommendations were to hold his cardura, metoprolol and norvasc so the blood pressure could be maintained 150-160 mmhg range; coumadin was resumed per his prior home dose.He was advised to continue with pt if needed.At the 30-day follow-up, the patient had an nih score of 1 and a rankin score of 0.No adverse event occurred after discharge.The patient is currently doing fine.The device remains implanted; therefore, it was 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 15860659 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 a stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.During a stroke, 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.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 after treatment of atropine and neo-synephrine.This may have occurred due to the stretch of the baro-receptors.There is no evidence to suggest that the event is related to the design or manufacturing process of the device.Review of the available information suggests that patient factors and/or vessel/lesion characteristics 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 failure/event does not appear to be related to the manufacturing process.
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Manufacturer Narrative
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The unknown neurological event, the minor facial paralysis that was noted during the 30 -day follow-up on march 20, 2014, was clarified to not be a new neurological event, but a continuation of the previously reported cva that occurred a month before the follow-up visit.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00182 and 1016427-2014-00027.Complaint conclusion updated with additional information: as reported by the (b)(4) study, the patient was a (b)(6) male with a medical history of two cabg surgeries in 1992 and 1998, hyperlipidemia, history of tia, prior right carotid endarterectomy, abnormal stress test, stage iv ckd, chronic anticoagulation, diabetes, aaa, repeat left renal artery angioplasty with stent placement, and repeat celiac axis angioplasty with stent placement, three strokes with ¿mild residual left-sided weakness¿, and left carotid /left subclavian artery bypass.The target lesion was located in the left proximal internal carotid artery with a length of 20mm and a diameter of 8mm.The eccentric lesion was severely calcified in a concentric and circumferential manner with the width greater than or equal to 3mm.The stenosis rate was 99% and there was no lesion thrombosis.The vessel was a type i arch vessel with moderate tortuosity and two or more bends.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was symptomatic before the procedure with transient left eye blindness.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was deployed at the target lesion before the stent was post-dilated with a 5x20mm non-cordis balloon catheter, leaving a final stenosis rate of 10%.The catheterization summary reported that post-stent dilation the patient had a period of asystole of 10 seconds and was immediately given atropine and neo-synephrine.During/after post-dilation of the stent, the patient began to suffer from a sudden onset of mild right facial droop, altered mental status, and right arm and leg weakness.He became less responsive, had a right facial droop, and was unable to speak.Subsequent angiogram showed good flow with normal cerebral flow, improved when compared to prior image in the system.Over the next 15 minutes with iv neo-synephrine, with improvement in blood pressure, he had significant improvement in his neurological status.He was able to complete a near full smile, follow commands, squeeze his right hand and move right foot, able to speak with mild difficulty - no issues with word finding or movement.The patient did have some mild hypotension (80-90 mmhg systolic blood pressure) for which he required a 0.4 mcg drip of neo-synephrine that was anticipated titrating off over the next 12 hours.The angioguard was successfully retrieved and found to have debris in the basket.There was none documented presence of air bubbles and the patient had a neurological deficit when leaving the angiography suite.Post-procedure, the nih stroke scale score was 1 due to right ¿very slight¿ facial droop.The rankin stroke scale score was 0.The patient was admitted to icu later that day.No ct/mri of the head was performed.The patient partially recovered with minor residual deficits of right mild facial droop.Post-intervention most of his blood pressure medications were held to ensure adequate cerebral perfusion.The patient was discharged two days after the event/procedure with an nih score of 1 and a rankin score of 0.Cva: post-procedural aphasia and hemiparesis; evaluated by neurology team and initial recommendations were to hold his cardura, metoprolol and norvasc so the blood pressure could be maintained 150-160 mmhg range; coumadin was resumed per his prior home dose.He was advised to continue with pt if needed.At the 30-day follow-up, the patient had an nih score of 1 due to minor facial paralysis (residual deficit from cva) and a rankin score of 0.No adverse event occurred after discharge.The patient is currently doing fine.The device remains implanted; therefore, it was 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 15860659 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 a stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.During a stroke, 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.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 after treatment of atropine and neo-synephrine.This may have occurred due to the stretch of the baro-receptors.There is no evidence to suggest that the event is related to the design or manufacturing process of the device.Review of the available information suggests that patient factors and/or vessel/lesion characteristics 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 failure/event does not appear to be related to the manufacturing process.
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