| Catalog Number PC0830RXC |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Atrial Fibrillation (1729); Stroke/CVA (1770); Infarction, Cerebral (1771)
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| Event Date 04/02/2014 |
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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 an onset of right hemiparesis and facial droop, which was diagnosed as a stroke (ischemic), after a procedure in which an 8x30mm precise pro rx stent was implanted.The patient partially recovered with minor residual deficits of arm weakness.During hospitalization, the patient developed atrial fibrillation and was treated with cardiac medications and coumadin.The patient was discharged a week after the procedure/neurological event.The target lesion was located in the left proximal internal carotid artery with a length 20mm and a reference diameter of 5mm.There was none documented calcification or vessel tortuosity.The vessel was a type 1 arch vessel.The lesion had a stenosis rate of 80% with no lesion thrombosis.At baseline, the nih score was 1 due to an asymmetrical smile, and the rankin score was 0.The patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was implanted at the lesion.The angioguard was successfully retrieved and found to have no debris in the basket.There was none documented presence of air bubbles, and the patient did not have a neurological event prior to leaving the angiography suite.Post procedure imaging demonstrated a patent stent.Post-operatively, the patient reports subjective right arm weakness but no objective weakness detected initially by primary team.However, 6 hours after the procedure, the patient had acute worsening with right arm weakness and facial droop.Neurology was called to bedside and evaluated the patient with initial nihss=5.The nih score was documented as 2 prior to the ct/cta.The patient denies any changes in vision, new numbness (has chronic neuropathy), difficulty speaking, or chest pain.She does complain of headache at vertex, which was mild and a feeling of right arm "heaviness".
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Manufacturer Narrative
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A mild right nasolabial fold flattening was observed.The patient sent to the ccu and was given heparin.The right arm hemiparesis improved to only right arm weakness overnight.During a cardiac review of the systems, it was found that the patient had intermittent chest discomfort that lasts for seconds and have been occurring for the last 8 months and chronic ankle edema.The patient was not a candidate for tpa.The patient was diagnosed with an ischemic stroke.The patient partially recovered with minor residual deficits of persistent right arm weakness.It was also reported that the subject was noted to have atrial fibrillation with rapid ventricular response (rvr) on the cardiac floor.She was given iv diltiazem and iv metoprolol in the acute setting and converted to sinus.She was then started on diltiazem by mouth and metoprolol as well as a heparin drip.Diltiazem was stopped secondary to hypotension, but the patient again went into a-fib with rvr.So,she was started on a amiodarone load.She then converted to sinus and continued on metoprolol and amiodarone.She was started coumadin for a chads2 score of 4.Her inr at discharge was 1.4 and she was being bridged with heparin gtt until at therapeutic goal of inr 2-3.The patient was discharged to rehab a week after the event with an nih score of 2 and a rankin score of 0.Which was later diagnosed as a stroke (ischemic).The device remains implanted in the patient; therefore, it is not available for analysis.A device history record (dhr) and additional information are pending and will be submitted 30 days upon receipt.Concomitant medications: pre and post procedure medications: cyanocobalamin, ferrous sulfate, fexofenadine, gabapentin, and glucosamine w/ chondroitin.Intra and post procedure medications include: clopidogrel and heparin.Medications only given post procedure: coumadin, diltiazem, and docusate sodium.Concomitant devices: 6mm angioguard catalog number 601814rmc, lot number 35220012.
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Manufacturer Narrative
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A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Complaint conclusion: as reported by the sapphire study, a patient had an onset of right hemiparesis and facial droop, which was diagnosed as a stroke (ischemic), after a procedure in which an 8x30mm precise pro rx stent was implanted.The patient partially recovered with minor residual deficits of arm weakness.During hospitalization, the patient developed atrial fibrillation and was treated with cardiac medications and coumadin.The patient was discharged a week after the procedure/neurological event.The patient was an (b)(6) female with a medical history of heart disease, aortic stenosis, pvd, hyperlipidemia, smoking (>5packs of cigarettes), hypertension and contralateral (right) carotid occlusion.The target lesion was located in the left proximal internal carotid artery with a length 20mm and a reference diameter of 5mm.There was none documented calcification or vessel tortuosity.The vessel was a type 1 arch vessel.The lesion had a stenosis rate of 80% with no lesion thrombosis.At baseline, the nih score was 1 due to an asymmetrical smile, and the rankin score was 0.The patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was implanted at the lesion.The angioguard was successfully retrieved and found to have no debris in the basket.There was none documented presence of air bubbles, and the patient did not have a neurological event prior to leaving the angiography suite.Post procedure imaging demonstrated a patent stent.Post-operatively, the patient reports subjective right arm weakness but no objective weakness detected initially by primary team.However, 6 hours after the procedure, the patient had acute worsening with right arm weakness and facial droop.Neurology was called to bedside and evaluated the patient with initial nihss=5.The nih score was documented as 2 prior to the ct/cta.The patient denies any changes in vision, new numbness (has chronic neuropathy), difficulty speaking, or chest pain.She does complain of headache at vertex, which was mild and a feeling of right arm "heaviness".A mild right nasolabial fold flattening was observed.The patient sent to the ccu and was given heparin.The right arm hemiparesis improved to only right arm weakness overnight.During a cardiac review of the systems, it was found that the patient had intermittent chest discomfort that lasts for seconds and have been occurring for the last 8 months and chronic ankle edema.The patient was not a candidate for tpa.The patient was diagnosed with an ischemic stroke.The patient partially recovered with minor residual deficits of persistent right arm weakness.It was also reported that the subject was noted to have atrial fibrillation with rapid ventricular response (rvr) on the cardiac floor.She was given iv diltiazem and iv metoprolol in the acute setting and converted to sinus.She was then started on diltiazem by mouth and metoprolol as well as a heparin drip.Diltiazem was stopped secondary to hypotension, but the patient again went into a-fib with rvr.So, she was started on an amiodarone load.She then converted to sinus and continued on metoprolol and amiodarone.She was started coumadin for a chads2 score of 4.Her inr at discharge was 1.4 and she was being bridged with heparin gtt until at therapeutic goal of inr 2-3.The patient was discharged to rehab a week after the event with an nih score of 2 and a rankin score of 0.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 15970464 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.An ischemic stroke 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; 80% of all strokes are ischemic.During ischemic 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.Atrial fibrillation is a chronic condition associated with cardio-pulmonary disease.Abnormalities or damages to the heart's structure are the most common cause of atrial fibrillation.Possible causes of atrial fibrillation include: high blood pressure, heart attacks, abnormal heart valves, congenital heart defects, an overactive thyroid or other metabolic imbalance, exposure to stimulants such as medications, caffeine or tobacco, or to alcohol, sick sinus syndrome ¿ improper functioning of the heart's natural pacemaker, emphysema or other lung diseases, previous heart surgery, viral infections, stress due to surgery or other illnesses.In some cases, no cause can be found.Based on the information provided, the cause of the atrial fibrillation reported is most likely related to the patient¿s medical history and the stress of the surgery.There is no evidence that manufacturing issues contributed to the reported events.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported events do not appear to be related to the manufacturing process.
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Manufacturer Narrative
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Additional information: the rankin score at discharge was corrected to 2.At the 30-day follow-up, the patient had an nih and rankin score of 1 with no additional adverse events.Complaint conclusion after adding in additional and modified information: as reported by the (b)(4) study, a patient had an onset of right hemiparesis and facial droop, which was diagnosed as a stroke (ischemic), after a procedure in which an 8x30mm precise pro rx stent was implanted.The patient partially recovered with minor residual deficits of arm weakness.During hospitalization, the patient developed atrial fibrillation and was treated with cardiac medications and coumadin.The patient was discharged a week after the procedure/neurological event.The patient was an (b)(6) female with a medical history of heart disease, aortic stenosis, pvd, hyperlipidemia, smoking (>5packs of cigarettes), hypertension and contralateral (right) carotid occlusion.The target lesion was located in the left proximal internal carotid artery with a length 20mm and a reference diameter of 5mm.There was none documented calcification or vessel tortuosity.The vessel was a type 1 arch vessel.The lesion had a stenosis rate of 80% with no lesion thrombosis.At baseline, the nih score was 1 due to an asymmetrical smile, and the rankin score was 0.The patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was implanted at the lesion.The angioguard was successfully retrieved and found to have no debris in the basket.There was none documented presence of air bubbles, and the patient did not have a neurological event prior to leaving the angiography suite.Post procedure imaging demonstrated a patent stent.Post-operatively, the patient reports subjective right arm weakness but no objective weakness detected initially by primary team.However, 6 hours after the procedure, the patient had acute worsening with right arm weakness and facial droop.Neurology was called to bedside and evaluated the patient with initial nihss=5.The nih score was documented as 2 prior to the ct/cta.The patient denies any changes in vision, new numbness (has chronic neuropathy), difficulty speaking, or chest pain.She does complain of headache at vertex, which was mild and a feeling of right arm "heaviness".A mild right nasolabial fold flattening was observed.The patient sent to the ccu and was given heparin.The right arm hemiparesis improved to only right arm weakness overnight.During a cardiac review of the systems, it was found that the patient had intermittent chest discomfort that lasts for seconds and have been occurring for the last 8 months and chronic ankle edema.The patient was not a candidate for tpa.The patient was diagnosed with an ischemic stroke.The patient partially recovered with minor residual deficits of persistent right arm weakness.It was also reported that the subject was noted to have atrial fibrillation with rapid ventricular response (rvr) on the cardiac floor.She was given iv diltiazem and iv metoprolol in the acute setting and converted to sinus.She was then started on diltiazem by mouth and metoprolol as well as a heparin drip.Diltiazem was stopped secondary to hypotension, but the patient again went into a-fib with rvr.So, she was started on an amiodarone load.She then converted to sinus and continued on metoprolol and amiodarone.She was started coumadin for a chads2 score of 4.Her inr at discharge was 1.4 and she was being bridged with heparin gtt until at therapeutic goal of inr 2-3.The patient was discharged to rehab a week after the event with an nih score of 2 and a rankin score of 2.At the 30-day follow-up, the patient had an improved nih and rankin score of 1.No additional adverse event occurred.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 15970464 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.An ischemic stroke 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.80% of all strokes are ischemic.During ischemic 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.Atrial fibrillation is a chronic condition associated with cardio-pulmonary disease.Abnormalities or damages to the heart's structure are the most common cause of atrial fibrillation.Possible causes of atrial fibrillation include: high blood pressure, heart attacks, abnormal heart valves, congenital heart defects, an overactive thyroid or other metabolic imbalance, exposure to stimulants such as medications, caffeine or tobacco, or to alcohol, sick sinus syndrome ¿ improper functioning of the heart's natural pacemaker, emphysema or other lung diseases, previous heart surgery, viral infections, stress due to surgery or other illnesses.In some cases, no cause can be found.Based on the information provided, the cause of the atrial fibrillation reported is most likely related to the patient¿s medical history and the stress of the surgery.There is no evidence that manufacturing issues contributed to the reported events.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported events do not appear to be related to the manufacturing process.
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Manufacturer Narrative
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The clinical events committee (cec) agreed that a cva-major, ipsilateral, ischemic/embolic occurred and was procedure and device-related.Additional details were received from the cec meeting minutes: after the procedure, the site reported a 0% final residual stenosis.The neurological event form reported event of ischemic stroke on (b)(6) 2014 with sudden onset of right hemiplegia or hemiparesis.The site reported that post-operatively the patient reported subjective right arm weakness but no objective weakness was initially detected by primary team.Around 16:30, the patient had acute worsening with right arm weakness and facial droop.Neurology was called to bedside and evaluated the patient with initial nih stroke scale score of 5.A follow-up neurological assessment on the same date on (b)(6) 2014 found improvement with the nih stroke scale score was 2 (facial palsy -1, motor right-1).Per exam description, there was right nasolabial fold flattening and right arm pronator drift.Neurology follow-up consultation on (b)(6) 2014 noted some initial improvement but reported it felt the right arm was weaker that morning.Neurology consultation impression: new onset of right upper extremity weakness secondary to superficial left mca infarcts confirmed by brain mri, likely artery to artery embolism (question of aortic source).No indication for anticoagulation from a neurological perspective, the patient is on dual antiplatelet therapy.On (b)(6) 2014 the nih stroke scale score was 2 and the rankin stroke scale score was 2.A monitor strip showed paroxysm of atrial fibrillation and the patient was administered heparin drip for newly diagnosed atrial fibrillation with a plan bridge to coumadin.Amiodarone was started.A follow-up note on (b)(6) 2014 reported the patient complained on difficulty with her right arm, hand.Exam noted right nasolabial fold flattening, limited extension of left shoulder (chronic), but otherwise full strength on the left side.Right arm: 3/5 shoulder extension.3/5 triceps, 1/5 finger extension.Right leg 5/5.The patient was discharged on (b)(6) 2014 on asa and clopidogrel.On (b)(6) 2014 at 30 day follow up, the nih stroke scale score was 1 and the rankin stroke scale score was 1.Additional details were received on medical history: history of total occlusion of the right ica without distal reconstitution additional lab results/tests provided: a head ct on (b)(6) 2014 was negative, and cta showed patent stent and no large vessel cut off (with known right ica occlusion).A brain mri on (b)(6) 2014 at 22:18 revealed bilateral punctate areas of embolic infarcts, left greater than right, suggestive of acute infarcts.There was no hemorrhage noted.Due to the new information reported, (b)(4).Complaint conclusion updated to include new information reported: as reported by the sapphire study, the patient was an (b)(6) female with a medical history of heart disease, aortic stenosis, pvd, hyperlipidemia, smoking (>5 packs of cigarettes), hypertension and contralateral (right) carotid occlusion.The target lesion was located in the left proximal internal carotid artery with a length 20mm and a reference diameter of 5mm.There was none documented calcification or vessel tortuosity.The vessel was a type 1 arch vessel.The lesion had a stenosis rate of 80% with no lesion thrombosis.At baseline, the nih score was 1 due to an asymmetrical smile, and the rankin score was 0.The patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device before pre-dilation was performed.Then, an 8x30mm precise pro rx stent was implanted at the lesion, leaving a final stenosis rate of 0%.The angioguard was successfully retrieved and found to have no debris in the basket.There was none documented presence of air bubbles, and the patient did not have a neurological event prior to leaving the angiography suite.Post procedure imaging demonstrated a patent stent.Post-operatively, the patient reports subjective right arm weakness but no objective weakness detected initially by primary team.However, 6 hours after the procedure, the patient had acute worsening with right arm weakness and facial droop.Neurology was called to bedside and evaluated the patient with initial nihss=5.The nih score was documented as 2 prior to the ct/cta.The patient denies any changes in vision, new numbness (has chronic neuropathy), difficulty speaking, or chest pain.She does complain of headache at vertex, which was mild and a feeling of right arm "heaviness".A mild right nasolabial fold flattening was observed.The patient sent to the ccu and was given heparin.The right arm hemiparesis improved to only right arm weakness overnight.Neurology consultation impression: new onset of right upper extremity weakness secondary to superficial left mca infarcts confirmed by brain mri, likely artery to artery embolism (question of aortic source).No indication for anticoagulation from a neurological perspective, the patient is on dual antiplatelet therapy.The nih stroke scale score was 2 and the rankin stroke scale score was 2.During a cardiac review of the systems, it was found that the patient had intermittent chest discomfort that lasts for seconds and have been occurring for the last 8 months and chronic ankle edema.The patient was not a candidate for tpa.The patient was diagnosed with an ischemic stroke, or cerebrovascular accident.The patient partially recovered with minor residual deficits of persistent right arm weakness.It was also reported that the subject was noted to have atrial fibrillation with rapid ventricular response (rvr) on the cardiac floor.She was given iv diltiazem and iv metoprolol in the acute setting and converted to sinus.She was then started on diltiazem by mouth and metoprolol as well as a heparin drip.Diltiazem was stopped secondary to hypotension, but the patient again went into a-fib with rvr.So, she was started on an amiodarone load.She then converted to sinus and continued on metoprolol and amiodarone.She was started coumadin for a chads2 score of 4.Her inr at discharge was 1.4 and she was being bridged with heparin gtt until at therapeutic goal of inr 2-3.The patient was discharged to rehab a week after the event with an nih score of 2 and a rankin score of 2.At the 30-day follow-up, the patient had an improved nih and rankin score of 1.No additional adverse event occurred.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 15970464 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.A cerebrovascular accident 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.80% of all strokes are ischemic.During ischemic 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.Atrial fibrillation is a chronic condition associated with cardio-pulmonary disease.Abnormalities or damages to the heart's structure are the most common cause of atrial fibrillation.Possible causes of atrial fibrillation include: high blood pressure, heart attacks, abnormal heart valves, congenital heart defects, an overactive thyroid or other metabolic imbalance, exposure to stimulants such as medications, caffeine or tobacco, or to alcohol, sick sinus syndrome ¿ improper functioning of the heart's natural pacemaker, emphysema or other lung diseases, previous heart surgery, viral infections, stress due to surgery or other illnesses.In some cases, no cause can be found.Based on the information provided, the cause of the atrial fibrillation reported is most likely related to the patient¿s medical history and the stress of the surgery.There is no evidence that manufacturing issues contributed to the reported events.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported events do not appear to be related to the manufacturing process.
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