|
The event was reported via the icad study in china.The 63-year-old male patient was admitted to the neurosurgery department on (b)(6) 2023, due to "severe basilar artery stenosis.¿ physical exam on admission revealed conscious mind, dysarthria, muscle strength of grade 5 in both left lower limbs and grade 4 in the right upper limb, abnormal gait, and shuffling of the right lower limb.The patient signed the consent form on (b)(6) 2023 for the study titled "implantation of intracranial stent (cerenovus enterprise 2 intracranial stent) in patients with severe symptomatic atherosclerotic intracranial artery stenosis: a chinese multicenter, prospective, single-arm target value study." on (b)(6) 2023, intraoperative angiography revealed severe basilar artery stenosis, with a stenosis rate of approximately 75%.The proximal and distal arteries of the basilar artery were normal.After evaluation, it was confirmed that the patient met all the inclusion criteria of the chinese icad study and did not meet any of the exclusion criteria.The patient was enrolled in the study, and a 4mm x 16mm enterprise 2 stent (encr401600 / lot# unknown) was implanted.Follow-up angiography showed improved blood flow, with residual stenosis of about 10%.The patient was transferred to the ward safely after the surgery without any discomfort.On physical examination, both pupils were equal in size and round and reactive to light, muscle strength was grade 5 in the left upper limb, grade 5 in the left lower limb, and grade 4 in the right upper limb, and there is right lower limb immobilization.The patient experienced exacerbation of right limb weakness on (b)(6) 2023.The reported adverse event was assessed by the investigator as mild in severity, not serious, not related to the study device, but possibly related to the surgery, and not an unanticipated adverse device effect (uade).The event was treated with an unspecified medication and is noted to be persistent with the outcome value entered as ¿symptom relief.¿ the event did not result to a required/ prolonged inpatient hospitalization, or permanent impairment in body function/ structure.On (b)(6) 2023, the patient experienced dysuria.The principal investigator assessed this event as moderate in severity, not related to the study device, nor related to the surgical procedure.The event was treated with an unspecified non-drug therapy and resolved without sequelae on (b)(6) 2023.The patient's condition improved and the patient was discharged on (b)(6) 2023.Physical examination on discharge: symptoms of weakness of right limbs had improved, dysarthria remained the same, muscle strength was grade 4 in the right limbs, and grade 5 in the left limbs.On 01-nov-2023, additional information was received.Per the additional information, the investigator contacted the subject for a six-month follow-up and learned that on an unspecified date in (b)(6) 2023, the patient had a sudden coma at home and expired on the way to the hospital.When inquiring about more details, the family members stated that the cause of the patient's death was not clear and were unwilling to provide further information.Therefore, the serious adverse event is reported "coma." per the pi, ¿considering the unclear cause of the patient's death and the absence of discomfort before the coma, in combination with postoperative angiography results, it is tentatively judged that the event is possibly unrelated to the device and possibly unrelated to the surgical procedure.¿ the procedure on (b)(6) 2023, resulted in improved blood flow, with residual stenosis of about 10%.The patient was transferred to the ward safely after the surgery without complaining of discomfort, and the patient was discharged from the hospital on (b)(6) 2023 with improved right sided weakness (muscle strength grade 4 out of 5; 5 being the strongest score), and continued dysarthria (weakness in the muscles used for speech).
|
|
Manufacturer¿s ref.No: (b)(4).Section b.2: date of date: the date of death is not available; the patient expired on an unspecified date in (b)(6) 2023.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section e.1: the initial reporter facility name and address are not reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.There was no device performance issue or device malfunction reported during the procedure.Per the additional information received on 01-nov-2023, death is a known potential complication associated with the use of the enterprise ii vascular reconstruction device and is listed in the instructions for use (ifu) as such.There were no alleged quality issues regarding the device, as the device performed as intended, and the residual stenosis after the procedure was 10% compared to a baseline stenosis of 75%.The pi assessed the event as possibly unrelated to the study device and to the surgical procedure.There may have been patient, procedural, and pharmacological factors that may have contributed to the reported adverse event with no indication of a device malfunction or defect.However, since there is no information that would dissociate the event from the used device (such as the cause of death), the event of ¿coma¿ and the outcome of ¿death¿ will be conservatively reported to the us fda under 21 cfr 803 with a classification of ¿death,¿ with an awareness date of 01-nov-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 for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
|
