| Catalog Number PC0940RXC |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982)
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| Event Date 12/03/2013 |
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Event Type
Injury
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Event Description
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As reported by the (b)(4) registry, the patient had a neurological event on the same day of the index procedure.Post-operatively, after pulling the sheath, the patient developed a large hematoma in the right groin which resulted in hypotension, which caused the neurological changes.The patient experienced behavioral change, aphasia, and right visual field loss.The duration of the event was >24 hours and fully resolved.The patient¿s symptoms were intermittent throughout stay.The event was not related to anticoagulation.The event was deemed unrelated to the cordis device and related to the index procedure.Emergency cea surgery was not required.Pre-procedure nih stroke scale score was 2 and rankin score was 1.Carotid artery stenting (cas) was performed on an 85% occluded lesion in the proximal right internal carotid artery of 12mm in length in a 6.0mm vessel diameter with moderate vessel tortuosity.The arch i eccentric lesion was mildly calcified.A 7mm basket angioguard embolic protection device was successfully deployed past the lesion and a 9x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 0%.There was no debris found in the filter upon retrieval.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient was discharged 10 days following the index procedure.Nih stroke scale was not performed.The rankin scale was 2.The patient had the 30-day follow-up and exited the study with no additional adverse events reported.
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Manufacturer Narrative
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This device is not available for testing and evaluation as the device remains implanted.Additional information is pending and will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Concomitant medications: heparin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Concomitant devices: angioguard rx catalog number 701814rmc, lot number 70913454.
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Manufacturer Narrative
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This is one of two products involved with the reported adverse event (s) and are associated manufacturer report numbers: 9616099-2014-00619 & 1016427-2014-00111.Addendum (26-sep-2014): additional information was provided by the study coordinator.As per the study coordinator, the ¿cva was a working diagnosis, however, [the physician] states the patient¿s neurological changes were due to the hypotension the patient suffered after pulling the sheath.The patient has since had a ct scan which did not indicate a cva.¿ the event did not occur during the index procedure.The patient had confusion, visual disturbances, and speech problems.The residuals included visual problems.Pressure was applied to the hematoma and the hematoma was monitored.The hypotension was treated with fluids, blood, and neosynephrine given to maintain systolic bp greater than 150.The neurological event was being monitored and serial neurological checks were being performed.A 5f sheath was introduced into the right femoral artery and exchanged to a 6f shuttle sheath.There was no difficulty removing the sheath.A closure device was not used for the procedure.The access site was the right femoral artery.The puncture site did not have visible calcium/plaque.A stent was not near the puncture site.The vessel did not have >50% stenosis at or near the puncture site.The target femoral site was not previously closed with any closure device or manual compression less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to the procedure.Multiple stick attempts were not made before arterial access was achieved.The patient was anticoagulated.8,000 units of heparin bolus was administered.Act was maintained over 250 seconds.The patient was in bed when the bleeding started.The patient was discharged 10 days post-procedure.Addendum (06-oct-2014): adjudication minutes were received indicating that the patient had a non-ipsilateral minor ischemic/embolic cerebrovascular accident (cva) approximately 5 days post index procedure (event date: 12/8/2013).Additional details were received from the clinical events committee (cec) meeting minutes that the patient has a medical history of mild aortic stenosis, mild to moderate mitral regurgitation, moderate tricuspid regurgitation, moderate pulmonary hypertension, and impaired ef of 55%.Pre-procedure, the nih stroke scale score was 2 due to partial hemianopia and one limb ataxia; the rankin stroke scale score was 1.No history of stroke or tia was noted.According to discharge summary information, prior to index procedure the patient had symptoms of floaters and blurry vision in the right eye that prompted carotid duplex ultrasound to be performed, which revealed a severe right ica stenosis.Following this, the patient was enrolled in the study.Admission diagnosis: asymptomatic severe right carotid stenosis.During the procedure, the patient was initiated on 50 mcg of neosynephrine due to blood pressure decrease following carotid stenting.Intra-procedure cerebral angiography showed a severe stenosis in the right middle cerebral artery; the anterior cerebral artery was normal.Post-procedure, the patient was admitted to the icu for further observation and management.Following removal of the sheath in the icu, the patient developed a large hematoma in the right groin, resulting in significant hypotension requiring hemodynamic support with neo-synephrine and global ischemia of the brain resulting in confusion, as per discharge summary.The nih stroke scale score was not evaluated.Fluid resuscitation was initiated, and transfusion of two units of prbcs was performed due to hemoglobin drop by two points, as reported in the discharge summary.The patient required hemodynamic support for a couple of days.Per progress note, next morning the patient¿s confusion improved significantly yet she was still on neo-synephrine for hemodynamic support.She reported no specific complaints other than fatigue and weakness.She was alert and oriented and her neurological evaluation at that time revealed no focal deficits.At night hours she developed increased dyspnea and orthopnea and had short runs of paroxysmal atrial tachycardia.Neo-synephrine was discontinued.The progress note two days post-procedure reported improvement in mental status.Neurological evaluation at that time revealed no focal neurological deficits.The patient was alert, awake, and oriented x 3.Assessment: status post carotid placement - stable; dyspnea due to volume overload, paroxysmal atrial fibrillation due to volume overload.The patient was diagnosed with uti and antibiotic therapy was initiated.Her hospital course was remarkable for acute respiratory failure three days post-procedure.Another episode of shortness of breath occurred 5 days following the procedure.Per pulmonary/critical care consultation, the patient had chf exacerbation and acute respiratory failure.The nurse noticed expressive aphasia reported in the progress notes.The nih stroke scale score assessment was not performed.Subsequent assessment by md was as follows: expressive aphasia, possible stroke due to ischemia from hypotension or embolic event.Plan: to continue current treatment, pt/speech evaluation; social service consults for placement to rehabilitation facility and transfer to imcu level of care.Subsequent progress note a week after procedure reported that right eye vision was absent in the right hemifield.Further it noted that her speech improved significantly but she felt that she still had some problems finding word.Assessment: status post carotid stent and possible right-sided cva with residual visual loss.Per discharge summary 10 days post procedure, speech and physical therapy evaluation was performed.The patient was ambulating with assistance, and it was felt she would benefit from continued physical therapy support for a couple of weeks following her discharge.Anticoagulation with coumadin was reinitiated in the hospital.The hospital discharge diagnoses included: post-procedural cerebrovascular accident; expressive aphasia, near completely resolved.The site reported that no neurology consultation was performed for this event.Following query, the site also confirmed that no brain mri was done.Pre-discharge the nih stroke scale score was not evaluated and the rankin stroke scale score was 2.The patient was discharged 10 days post-procedure to a nursing skilled facility for continued physical therapy on asa, clopidogrel, and coumadin.At 30-day follow-up visit, the md-dictated office visit note reported: the patient slowly recovered but still continued to have some expressive aphasia; right homonymous hemianopsia was also persistent.Neurologically, she was found to be positive for speech changes and gait disturbances.She was oriented to time, person, and place.Impression and plan: she had been steadily improving in regards to speech and ambulation; vision in the right eye still remained impaired.A subsequent follow-up visit was planned.Follow-up duplex carotid ultrasound was to be scheduled at the closest date available.The nih stroke scale score results, evaluated by another person than md who performed the follow-up visit, was 2 with attribution to partial hemianopia and one limb ataxia.The rankin stroke scale score was 2.Carotid duplex ultrasound was performed two and a half months post-procedure, revealing a patent stent in the right carotid artery with normal flow parameters.The patient was seen in the office for her two-month follow-up visit.At that time, she still had visual problems and felt that her speech was ¿almost normal.¿ she reported steady improvement and denied any other new specific issues.A brain ct scan performed 4 months post-procedure compared to pre-procedure ct scan, revealed the following, according to the radiology report: no acute intracranial hemorrhage or mass effect; encephalomalacia involving the left occipital lobe, left posterior cerebral artery territory; white matter changes of chronic microvascular ischemic disease; stable atrophy.The site reported ¿other¿ neurological event on and did not report a stroke, stating that the patient had no stroke and all post-procedure neurological deficits were due to hypotension and chf exacerbation in presence of a negative ct scan.Addendum (09-oct-2014): additional information was provided indicating that a cook shuttle sheath was used for the procedure.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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This is one of two products involved with the reported adverse event (s) and are associated manufacturer report numbers: 9616099-2014-00619 & 1016427-2014-00111.Complaint conclusion: as reported by the (b)(4) registry, the patient had a neurological event on the same day of the index procedure.Following removal of the sheath in the icu, the patient developed a large hematoma in the right groin, resulting in significant hypotension requiring hemodynamic support with 50 mcg neo-synephrine to maintain systolic bp over 150 and global ischemia of the brain resulting in confusion, as per discharge summary.During the procedure, the patient was initiated on 50 mcg of neosynephrine due to blood pressure decrease following carotid stenting.As per the study coordinator, the ¿cva was a working diagnosis, however, [the physician] states the patient¿s neurological changes were due to the hypotension the patient suffered after pulling the sheath.The patient has since had a ct scan which did not indicate a cva.¿ the patient had confusion, visual disturbances, and speech problems.The residuals included visual problems.Pressure was applied to the hematoma and the hematoma was monitored.Fluid resuscitation was initiated, and transfusion of two units of prbcs was performed due to hemoglobin drop by two points, as reported in the discharge summary.The patient required hemodynamic support for a couple of days.Per progress note, next morning the patient¿s confusion improved significantly yet she was still on neo-synephrine for hemodynamic support.She reported no specific complaints other than fatigue and weakness.The neurological event was being monitored and serial neurological checks were being performed.Adjudication minutes were received indicating that the patient had a non-ipsilateral minor ischemic/embolic cerebrovascular accident (cva) approximately 5 days post index procedure.Pre-procedure, the nih stroke scale score was 2 due to partial hemianopia and one limb ataxia; the rankin stroke scale score was 1.No history of stroke or tia was noted.According to discharge summary information, prior to index procedure the patient had symptoms of floaters and blurry vision in the right eye that prompted carotid duplex ultrasound to be performed, which revealed a severe right ica stenosis.Following this, the patient was enrolled in the study.Carotid artery stenting (cas) was performed on an 85% occluded lesion in the proximal right internal carotid artery of 12mm in length in a 6.0mm vessel diameter with moderate vessel tortuosity.The arch i eccentric lesion was mildly calcified.A 5f sheath was introduced into the right femoral artery and exchanged to a 6f cook shuttle sheath.A 7mm basket angioguard embolic protection device was successfully deployed past the lesion and a 9x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 0%.There was no debris found in the filter upon retrieval.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient was discharged 10 days following the index procedure.Nih stroke scale was not performed.The rankin scale was 2.The patient had the 30-day follow-up and exited the study with no additional adverse events reported.The (b)(6) patient has a medical history of mild aortic stenosis, mild to moderate mitral regurgitation, moderate tricuspid regurgitation, moderate pulmonary hypertension, impaired ef of 55%, hyperlipidemia, cardiac arrhythmia, diabetes mellitus, hypertension, and high risk criteria age > 75.The product was not returned for analysis as it remains implanted.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Hypotension is a well-known potential adverse event associated with the carotid stent implantation procedure.The hemodynamic instability that occurs both during and after carotid stent implantation is influence by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds, 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.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.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.There is no evidence that manufacturing issues contributed to the events reported.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.Therefore, no corrective action will be taken.
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