MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Ischemia Stroke (4418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref no: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 6812678.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.There was no intra-operative device performance issue or device malfunction reported during the procedure.Cerebral infarction is a known potential complication associated with the use of the enterprise2 stent - vascular reconstruction device and is listed as such in the instructions for use (ifu).Blood pressure increase and muscle cramps are both common occurrences after a stroke and are attributed to the loss of cerebral autoregulation (referenced literature article #2).The principal investigator (pi) assessed the cerebral infarction as a serious adverse event, moderate in severity, and possibly unrelated to the enterprise2 stent study device, but possibly related to the surgical procedure.However, because the event occurred one day after the procedure, the correlating relationship between the cerebral infarction event to the device cannot be ruled out.Additionally, the event resulted in prolonged hospitalization and medication required for treatment.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 under the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.References: l l, x w, z y.Ischemia-reperfusion injury in the brain: mechanisms and potential therapeutic strategies.Biochem pharmacol (los angel).2016;5(4):213.Doi: 10.4172/2167-0501.1000213.Epub 2016 jun 20.Pmid: 29888120; pmcid: pmc5991620.Wong aa, read sj.Early changes in physiological variables after stroke.Ann indian acad neurol.2008 oct;11(4):207-20.Doi: 10.4103/0972-2327.44555.Pmid: 19893676; pmcid: pmc2771993.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.

Event Description

The event was reported via the icad study in china.A patient of unknown age, gender and medical history underwent a vascular stent placement procedure on (b)(6) 2023, to treat a severe stenosis of the basilar artery that was seen on intraoperative angiography, and an enterprise 2 stent (catalog / lot# unknown) was implanted.One day after the procedure, the patient suffered a medullary infarction: symptomatic intracranial arterial stenosis within the vascular region, increased blood pressure, and muscle cramps.Medication treatment was required and the patient¿s hospitalization was prolonged.It was reported that on (b)(6) 2023, the patient was admitted to the hospital two months after suffering a brain infarction.On (b)(6) 2023, the patient signed the "intracranial stent implantation in patients with severe symptomatic atherosclerotic intracranial artery stenosis (cerenovus enterprise 2 intracranial stent): a chinese multi-center, prospective, single-arm target value study" informed consent form, no.0114.It was confirmed before the operation that the patients met all the inclusion criteria and did not meet any of the exclusion criteria.On (b)(6) 2023, severe stenosis of the basilar artery was seen in the intraoperative angiography, and a 4mm x 23mm enterprise stent was implanted.The implanted stent covered the lesion entirely, with residual stenosis of the vessel being ¿about 26.9%¿.The patient had no discomfort after the procedure and was transferred to the intensive care unit (icu).On (b)(6) 2023, the patient returned to the ward.The measured blood pressure (bp) was 152/74 mmhg.High blood pressure, p: 80 beats / min, r: 20 breaths / min.Both pupils equal in size 0.25 cm, light response (±), glasgow coma scale 15 points, modified early warning score (mews) was 1 point.At 03:07 on (b)(6) 2023, the patient complained of left leg cramps for 5 minutes, and the corner of the mouth was skewed to the right.Measured bp 140/80 mmhg, spo2: 97%, the muscle strength of the left limbs was grade ii, and the muscle strength of the rest limbs was grade v, measured t: 38.9°c, physical cooling with ice packs as instructed, and continued observation.At 15:08 on (b)(6) 2023, the measured bp: 173/94 mmhg, the patient's blood pressure was high, and 1 tablet of nifedipine was given sublingually.On the same day, magnetic resonance imaging (mri) plan scan was performed.The results showed : the absorption period of the infarct in the left temporal and occipital lobe changed, a few recent infarction lesions in the left cerebellar hemisphere and brainstem, multiple ischemic lesions in both frontoparietal lobes and lateral ventricles, the left basal ganglia, thalamus, and brainstem; mild brain atrophy.The patient¿s symptom stabilized and is recovering after the following medication regiment: aspirin 100 mg q.D.P.O (once a day orally), clopidogrel q.D.P.O, atorvastatin calcium tablet q.N.P.O (once day at night), metoprolol sustained release tables q.D.P.O, amlodipine tablets q.D.P.O, and edaravone 30 mg b.I.D.(twice daily) intravenous infusion.The measured bp: 159/91 mmhg, p: 84 beats / min, r: 20 breaths / min, both pupils equal in size 0.25 cm, light response (±), gcs 15 points.The patient is planned to be discharged tomorrow, and the patient will be discharged with medicine.After discharged, the patient is planned to receive further rehabilitation therapy in the rehabilitation hospital, and the patient will be followed up by neurosurgery.This event was considered to be new infarction caused by the involvement of the perforator of the right vertebral artery; therefore, it was considered that it was possibly unrelated to the investigational device but was possibly related to the procedure.The cerebral infarction, which was considered a cerebral ischemia-reperfusion injury, was assessed by the principal investigator (pi) as a serious adverse event, moderate in severity, and possibly unrelated to the enterprise2 stent - vascular reconstruction device, but possibly related to the surgical procedure.The event prolonged inpatient hospitalization and required medicinal treatment.Symptoms are reported to be persistent and ongoing.There were no reported device deficiencies.On 16-aug-2023, additional information was received from the icad clinical study team.The information indicated the patient is a 54-year-old male with a history of cerebral infarction, hypertension, and diabetes.The patient exhibited leg cramps for 5 minutes, and the corner of his mouth was skewed to the right.Blood pressure measured was bp140/80 mmhg, spo2: 97%, the muscle strength of the left limbs was grade ii, and the muscle strength of the rest limbs was grade v.The device used and implanted was a 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / 6812678).On 17-aug-2023, additional information was received from the icad clinical study team.The information indicated that the patient experienced abnormal blood pressure on (b)(6)2023.The pi assessed the event as moderate in severity, not serious, unrelated to the study device, and unrelated to the surgical procedure.The patient was treated with medication for symptom relief.The symptoms are documented as persistent.The patient has a history of hypertension and it was reported that the patient suffered from hypertension after the procedure.

• Brand Name: ENTERPRISE2 4MMX23MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17620067
• MDR Text Key: 321920291
• Report Number: 3008114965-2023-00591
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 6812678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male