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It was reported, via the icad/enterprise2 post-market clinical study (b)(4), that on (b)(6)2022, a 53-year-old male patient (b)(6) underwent a vascular stent placement procedure for ¿severe stenosis of the right middle cerebral artery m1 segment (mca)¿ using an unkenterprise2 stent - vascular reconstruction device (product code/lot#: unknown).It was reported that after the procedure, the stent completely covered the lesion, and the angiographic residual stenosis was ¿about 29.9%¿.There were no reported device deficiencies related to the enterprise2 stent.The patient was discharged on (b)(6) 2022 with antiplatelet, nonsteroidal anti-inflammatory (nsaid), anti-cholesterol, anti-hypertension, and anti-diabetic medications.On (b)(6) 2023, approximately six months and 29 days later, the patient was seen in the hospital for a follow-up cerebral angiography and no intra-stent occlusion was found.On (b)(6) 2023, approximately 10 months and 2 days after the procedure, the patient experienced the event of ¿left limb weakness¿.The patient was admitted to the hospital for sudden left sided weakness, difficulty speaking, and partial facial paralysis that lasted two days.The event was assessed by the treating physician as an anticipated, serious adverse event, moderate in severity, that was unrelated to the study device, and unrelated to the surgical procedure.The event resulted in the patient being hospitalized for further diagnosis and an in-patient surgery.The patient was treated with ¿reperfusion therapy¿, although exact details of this treatment are unknown.A ¿head mr plain scan¿ showed recent infarcts with softening lesions of the right frontal parietal temporal occipital lobe and basal ganglia area¿, as well as ¿ischemic lesions at the frontal and parietal lobes and lateral ventricles¿.It was also found that the patient had maxillary sinusitis and a ¿partly empty sella¿ (pituitary gland shrinks or becomes flattened; can be treated with hormone therapy).On (b)(6) 2023, the patient underwent the diagnostic procedure of ¿digital subtraction angiography (dsa) under local anesthesia¿, which showed plaque formation at the beginning of the right internal carotid artery, mild stenosis of the lumen, and occlusion of the right middle cerebral artery stent¿, with nearby parent vessels compensating for the stenotic and occluded vessels.It was decided that the infarcts were medium in size and the patient would be treated conservatively, with antiplatelet, ¿lipid-lowering, fluid replacement and other drugs¿.The event of ¿left limb weakness¿ was attributed to the subject's irregular intake of anticoagulant medication.It was also reported that the patient had poor blood sugar control in the past, based on the glycosylated hemoglobin (hba1c test) lab result of 8.4% (measures the average blood sugar levels over the past 3 months), which can also contribute to the event.The event was reported as not persistent and ¿symptom disappeared with sequelae¿ with an end date on (b)(6) 2023.The patient¿s condition was deemed stable and was then discharged from the hospital (date unknown).There were no reported device deficiencies related to the enterprise stent, and the device remains implanted in the patient.The event was reported as such: ¿the patient was admitted to the hospital due to crooked mouth and slurred speech 15 days on (b)(6) 2022, and signed an informed consent form, "implantation of an intracranial stent in patients with severe symptomatic atherosclerotic intracranial artery stenosis (cerenovus enterprise 2 intracranial stent): a multicenter, prospective, single-group, objective-value study in china" on (b)(6) 2022, with the number (b)(4).Preoperatively, it was confirmed that the patient met all the inclusion criteria and was enrolled after not meeting any of the exclusion criteria.On (b)(6) 2022, severe stenosis of the right middle cerebral artery m1 segment was seen on intraoperative angiography, and an enterprise 2 4.0 23mm stent was implanted, and the residual stenosis of the follow-up angiography was about 29.9%, and the stent had completely covered the lesion.The patient was discharged from the hospital on (b)(6)2022 without any discomfort after the operation.The subject was discharged with medicines: aspirin 100 mg qd po; rosuvastatin calcium tablets 10 mg qn po; ticagrelor tablets 90 mg bid po; amlodipine tablets 5 mg qd po; metformin tablets 500 mg bid po; celecoxib capsules 0.2 g bid po; sitagliptin tablets 100 mg qd po; acarbose tablets 0.1 g tid po; mecobalamin tablets 0.5 mg tid po.The subjects returned to the hospital for cerebral angiography after surgery 6 months (on (b)(6) 2023), and no intrastent restenosis was found after right middle cerebral artery stenting.On (b)(6) 2023 the investigator knew that on (b)(6) 2023 the patient went to the emergency neurology department of (b)(6) hospital affiliated with (b)(6) university due to sudden onset of left side limb weakness, with a nhiss score of 7 (conjugate 1 + facial palsy 1 + upper left 3 + lower left 2).There was a reperfusion therapy for this episode (details are unknown), and the patient had left limb weakness for 2 days, and the patient was admitted to the department of neurology for further diagnosis, with a plan to have an angiogram tomorrow.The patient's left limb was weak for 2 days, and he was admitted to the department of neurology for further diagnosis and treatment, and an angiography examination is planned for tomorrow.This event resulted in the patient's hospitalization, thus, it was reported as an sae.It is likely attributed to the subject's irregular intake of anticoagulant medication and judged to be unrelated to the investigational device or the study procedure.The first report of sae has been reported on (b)(6) 2023, and follow-up reports will be reported after further treatment.Today, it is learned that the patient has completed the relevant examinations after admission, head mr plain scan: the right frontal parietal temporal occipital lobe and basal ganglia area with recent infarcts with local softening lesions; both frontal and parietal lobes and lateral ventricle ischemic lesions; bilateral screening sinus and maxillary sinusitis; partly empty sella.After excluding contraindications, dsa angiography under local anesthesia on (b)(6) 2023 showed plaque formation at the beginning of the right internal carotid artery, mild stenosis of the lumen, and occlusion of the right middle cerebral artery stent.Compensation: the pia mater of the right anterior cerebral artery compensates to the blood supply area of the middle cerebral artery, and the pia mater branch of the right posterior cerebral artery compensates to the right temporal lobe.Considering that the patient's current infarct size is medium, interventional treatment is not given for the time being, and conservative treatment with aspirin + ticagrelor antiplatelet (clopidogrel is moderate metabolism), atorvastatin lipid-lowering, fluid replacement and other drugs.Considering that the patient's condition was stable, he was discharged.Submit the follow-up and summary report now.Whether antithrombotic therapy during hospitalization: yes.Start antiplatelet therapy at 00:00 on (b)(6) 2023 after admission: specific drug and dose: aspirin, others: ticagrelor.Main medications during hospitalization: aspirin enteric-coated tablets 100 mg qd po are mainly used for anti-platelet aggregation.Ticagrelor 90 mg bid po is mainly used for anti-platelet aggregation.Atorvastatin calcium tablets 40 mg qn po are mainly used for lipid-lowering and plaque-fixing.Amlodipine tablets 5 mg qd po are mainly used to lower blood pressure.Metformin tablets 500 mg qd po are mainly used to control blood sugar.Gliclazide sustained-release tablets 30 mg qd po are mainly used to control blood sugar.Butylphthalide and sodium chloride injection start date: on (b)(6) 2023 100 ml bid intravenous infusion end date: on (b)(6) 2023 mainly used to improve neurological deficits in acute ischemic stroke.Tanshinone a injection start date: on (b)(6) 2023 50 mg qd intravenous infusion end date: on (b)(6) 2023 mainly used to improve cerebral blood supply.Edaravone injection start date: on (b)(6) 2023 30 mg qd intravenous infusion end date: on (b)(6) 2023 mainly used for acute ischemic stroke.Edaravone injection start date: on (b)(6) 2023 30 mg bid intravenous infusion end date: on (b)(6) 2023 mainly used for acute ischemic stroke.During hospitalization, the patient was found poor blood sugar control in the past, with glycosylated hemoglobin at 8.4%.The adjusted hypoglycemic regimen was diamicron 60 mg qd + metformin 500 mg po tid + sitagliptin 100 mg po qd, and the blood sugar resolved compared to before¿.On 07-sep- 2023, additional/modified information was received regarding the event of ¿left limb weakness¿.The event term was changed to ¿brain infarction¿ and the assessment from the principal investigator (pi) was changed from ¿unrelated to the study device, and unrelated to the surgical procedure¿ to ¿possibly unrelated to the study device and unrelated to the surgical procedure¿.The patient¿s status was updated from ¿not persistent and symptom disappeared with sequelae with an end date on (b)(6) 2023¿ to ¿persistent: yes¿ and ¿symptom resolved¿ with an end date of ¿blank¿.It was also learned that the patient stopped taking their anti-cholesterol medications on (b)(6) 2023, which was thought to be a contributing factor of the event.The new information was reported as such: ¿considering that angiography in the patient's 6-month postoperative follow-up showed no in-stent stenosis on (b)(6) and the event occurred after the patient discontinued statins on (b)(6) 2023, the sae was considered to be related to the discontinuation of statins, and the sae was re-considered to be possibly unrelated to the investigational device and the study procedure.Follow-up reports are now reported and the diagnosis of adverse events is updated as "brain infarction".
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Product complaint#: (b)(4).Section a1.Patient identifier: (b)(6).Cerebral infarction is a known potential complication associated with the use of the enterprise2 stent device and is mentioned in the instructions for use (ifu) as such.There were no reported quality issues/ malfunctions related to the enterprise2 stent device, as the device performed as intended, completely covering the lesion with residual stenosis being 29.9% after the surgical procedure.Per the principal investigator¿s assessment, the adverse event of ¿brain infarction¿ was possibly unrelated to the device, and unrelated to the surgery.The event was attributed to the patient¿s irregular intake of anticoagulant medication and the interruption of their anti-cholesterol medications on (b)(6) 2023.However, the event required prolonged hospitalization, a surgical intervention and medicinal treatment, and the correlating relationship between the event to the device cannot be ruled out.Therefore, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury¿, with an awareness date of 07-sep-2023.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Product complaint#: (b)(4).Updated sections on this medwatch: h6 (health effect - clinical code).Additional information was received on 20-dec-2023.Summary: in ¿2023,¿ the patient experienced the event of ¿right middle cerebral artery occlusion after stent implantation,¿ which became known to the site on (b)(6) 2023.The pi assessed this event as not serious, but severe in severity, and as possibly unrelated to the study device, and unrelated to the surgical procedure.The event was not an unanticipated adverse device effect (uade) and there were no device deficiencies related to the event.The event was not classified as neither an ischemic stroke nor a symptomatic cerebral hemorrhage.The event was not medically treated, and the outcome is recorded as ¿ongoing symptom¿ with no end date listed.The event did not lead to prolong inpatient hospitalization, fatal injury/illness, or death.The device remains implanted for continued use.Per the additional information received on 20-dec-2023, the patient experienced the event of ¿right middle cerebral artery occlusion after stent implantation¿ on an unknown date, which was assessed by the pi as possibly unrelated to the study device.There may have been patient and pharmacological factors that contributed to the event, such as the patient¿s noncompliance with anticoagulant and anti-cholesterol medications.However, based on the assessment of the pi, the correlation between event to the used device, cannot be ruled out.Additionally, although no specific intervention is stated, it would be clinically reasonable to assume a ¿severe¿ cerebral arterial occlusion would require an intervention to preclude patient harm.Based on this information, this event does meet us fda reporting criteria under 21 crf 803 with the classification of ¿serious injury,¿ with an awareness date of 20-dec-2023.The file will be re-reviewed if additional information is received at a later date.
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