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Adjudication minutes were received indicating that the patient had a minor ipsilateral and non-ipsilateral cerebrovascular accident (cva) - ischemic/embolic occurring two days following the index procedure.The event was deemed related to the procedure and device.The minutes noted that the death occurring 29 days post-procedure was neurologically related and was related to the index procedure.The additional information received do not provide supporting data to justify the neurogic etiology diagnosis.The death certificate recorded the immediate cause of death as chronic obstructive lung disease with congestive heart failure listed as an underlying cause.In addition, the primary investigator commented that he felt that the death was cardiac related, an arrythmia.Additional details were received from the clinical events committee (cec) meeting minutes that pre-procedure the patient was seen for ongoing visual disturbances that started a year prior.Per neurology consultation note, this started with dark floaters that further had changed in color (mostly pink) and shapes.The patient denied any harmful visual imaging: he did not see images like snakes, people, or insects.There was history of seizures or stroke, and denied any new lateralized weakness or numbness.A brain mri five days before the procedure revealed no evidence of acute cerebrovascular accident, mass, or intracranial hemorrhage.Chronic deep white matter small vessel ischemia was suspected.Per neurology consultation report, the patient was not seen by an eye doctor, and his visual problems were assessed as a local eye problem: lens vs.Macular degeneration.The procedure was reported to be uncomplicated.Post-procedure, the following day, the site reported the nih stroke scale score of 0 and the rankin score of 0.Per hospitalist progress note, nursing records from two days post-procedure indicated that the patient was restless all night, attempting to climb out of bed, throwing objects on the floor and insisting that he speaks with his wife.The wife was called and spoke with the patient.He was agitated, would not stay in a recliner chair.The patient was returned back to the bed with a bedside sitter.Per discussion with the patient¿s wife, she indicated that he had some problems with memory since previous year, forgetting various items around house, unable to operate a new computer, while by occupation he was a system analyst in computer industry; he also had problems with visual hallucinations, more so recently when he was seeing various people who were not there.Prior to that, he had reported seeing various colored floaters, which were discussed in pre-procedure consultation.According to the wife, however, the patient¿s current degree of agitation appeared to be new.Physical examination found the patient alert, but restless.He recognized his wife, was oriented to year, but not to place or month.He recognized faces of two of his visitors, but was confused as to the names of both of them.There were no focal neurological deficits found.The patient was not cooperative enough to perform a sensory examination.He had a slight snout reflex.There were bilateral flexor plantar responses.Assessment and plan were the following: the patient appeared to suffer from encephalopathy, probably toxic on top of suspected baseline dementia.If there is no difference in behavior in 24-hours, an mri should be obtained to determine whether there is any evidence of a cerebral infarction.An mri performed 4 days post-procedure revealed the following, according to the radiology report: interval development of small focus of diffusion restriction at left frontal lobe subcortical region; a small focus cortical focus of diffusion restriction at right parietal lobe right parasagittal region, findings consistent with lacunar infarct common may be related to thromboembolic event such as from cardiac source, given cortical subcortical distribution and bilateral distribution.Per discharge summary ¿over the past 48 hours the patient had significant improvement, no longer needing one-on-one observation.¿ the hospitalist progress note impression a week after procedure: initial presentation for syncope, cause thought to be multifactorial with underlying conduction system disease and severe underlying coronary artery disease; three-vessel coronary artery disease, status post cardiac catheterization, with ef of 30%.Initial plan was for cabg surgery.At this point, the patient is being triaged to medical management due to significant underlying comorbidities.Metabolic encephalopathy, thought multifactorial, initial concern was for stroke, the patient was seen by neurology, also for possible alcohol use at home; the patient was profoundly confused, now his mentation had improved, and he is currently awake, alert, oriented x2, unsure of the exact date.Carotid artery disease, status post stent placement; valvular heart disease with mitral regurgitation noted.Severe copd, seen and evaluated by pulmonary medicine during hospitalization.The patient was placed on spiriva with albuterol around the clock and was already on high doses of advair.Hypotension: blood pressure was running low yesterday, await cardiology follow-up, currently aldactone and zestril being held.The discharge summary impression: the patient experienced ¿organic brain syndrome with significant in-hospital exacerbation (icu psychosis), which was exacerbated by the development of multifocal lacunar infarcts with mri of the brain demonstrating interval development of small foci of diffusion restriction in left frontal lobe subcortical region and right parietal lobe, right parasagittal region consistent with lacunar infarcts since previous mri.The patient was discharged on a week after the index procedure to a rehabilitation facility on asa and clopidogrel.The patient expired on 29 days following the index procedure.The death certificate reported the cause of death as chronic obstructive lung disease and congestive heart failure.The pi provided a note that stated that prior to the index procedure the patient had intermittent episodes of confusion, requiring one-on-one nursing care that persisted post-procedure up until time of discharge.Consent to perform the procedure was obtained from the wife and son, and at no time did the patient have any focal neurological deficits before or after the procedure.An mri performed after the procedure did demonstrate small focus of diffusion restriction at the left frontal lobe subcortical region and a small cortical focus of diffusion restriction at the right parietal lobe parasagittal region consistent with lacunar infarct commonly associated with thromboembolic disease from a cardiac source.¿this does not represent a stroke in my opinion based on the protocol definition, as there were no focal neurological findings.¿ it further noted that the patient passed away 22 days after his discharge from the hospital.His death was sudden.His wife relayed that he had been seen earlier in the morning, alert and oriented and without complaints, and was found by nursing home personnel 1 hour later slumped over chair unresponsive.He was pronounced dead.The pi note further stated: "the patient¿s death was certified as secondary to copd; in retrospect though, given the severity of his lv systolic dysfunction, i strongly suspect that he had an arrhythmia." the site reported the cause of death was other, medical.Complaint conclusion: as reported by the (b)(4) registry the (b)(6) male patient expired approximately 29 days post index procedure.The cause of death was medical (neoplasm, renal, etc.).The patient was found deceased and an autopsy was not performed.According to the death certificate, the immediate cause of death was identified as chronic obstructive lung disease with congestive heart failure listed as an underlying cause.The event was deemed unrelated to the index procedure and cordis device.Adjudication minutes received indicated that the patient had a minor ipsilateral and non-ipsilateral cerebrovascular accident (cva) ¿ischemic/embolic that occurred two days post-procedure.The event was deemed related to the procedure and device.Nursing records indicated that the patient was restless all night, attempting to climb out of bed, throwing objects on the floor and insisting that he speak with his wife.Per discussion with the patient¿s wife, she indicated that he had some problems with memory since previous year, forgetting various items around the house, unable to operate a new computer, while by occupation he was a system analyst in computer industry.He also had problems with visual hallucinations.Mri was performed.Pre-procedure nih stroke scale score was 0 and rankin score was 0.Carotid artery stenting (cas) was performed on an 84% occluded lesion in the proximal left internal carotid artery of 20mm in length in a 6.0mm vessel diameter with mild vessel tortuosity.The lesion was eccentric, ulcerated, and moderately calcified.A 6mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated.A 9x30mm precise pro rx stent was successfully deployed at the target lesion.The angioguard was retrieved with no debris found in the filter.The residual diameter stenosis measured 0%.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient was discharged a week following the index procedure to a rehabilitation facility.The patient expired 22 days after discharge from the hospital.His death was sudden.The patient has a medical history of synchronous, severe cardiac and carotid disease requiring open-heart surgery and carotid revascularization, severe pulmonary disease, hyperlipidemia, clinical copd, history of smoking, coronary artery disease, hypertension, and high-risk criteria: chf (class iii/iv) and/or known severe left ventricular dysfunction lvef<35% and synchronous severe cardiac & carotid disease requiring open heart surgery & carotid revascularization and severe pulmonary disease and age > 75.The complaint device 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.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.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.There is no evidence that manufacturing issues contributed to the events.Therefore, no corrective actions will be taken at this time.
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