MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401600

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

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891)

Event Date 04/04/2023

Event Type  Injury  

Event Description

As reported via the icad study in china, a 52-year-old male ((b)(6)) who underwent vascular stent placement with an enterprise2 4mmx16mm no tip (encr401600, 7469261) reconstruction device on (b)(6) 2023, on the same day as the surgical procedure, the patient experienced a cerebral hemorrhage, which was assessed by the pi as severe in severity, unrelated to the study device, but possibly unrelated to the surgical procedure.There was no device deficiency, there was no ischemic stroke, but the cerebral hemorrhage was symptomatic.The outcome of the event was ¿symptom resolved¿.The event required or prolonged inpatient hospitalization.Per the intake form provided: ¿intraoperative imaging on (b)(6) 2023 revealed severe stenosis of the c6 segment of the right internal carotid artery with a stenosis of approximately 83%.The patient was confirmed to be enrolled and a test stent was implanted, with postoperative stenosis of less than 40%, the stent having completely covered the lesion.The patient returned to the ward safely without complaining of discomfort.On (b)(6) 2023, after the operation, the patient suddenly had a headache, accompanied by irritability and slurred speech.Rescue measures: immediately stop the use of tirofiban, and urgently check the bedside ct, suggesting ventricular hemorrhage, and was transferred to the icu, where the patient was intubated and put on a ventilator for assisted respiration.The lateral ventricle was punctured and drained.The cause of the hemorrhage was considered to be the restoration of the diameter of the stenotic vessel after stent angioplasty and the dramatic increase in blood flow in a short period of time leading to cerebral hemorrhage, which was the result of reperfusion injury.It was judged to be not related to investigational product and possibly unrelated to the surgery.On (b)(6) 2023, aspirin enteric-coated tablets (100mg, qd) were given.From (b)(6) 2023 to (b)(6) 2023, the patient was in sedated and analgesic status.Physical examination: unresponsive to light, no voluntary movement of extremities, intracerebroventricular urokinase injection given.From (b)(6) 2023 to (b)(6) 2023, the patient was in sedated and analgesic status¿.¿physical examination: reactive to light, no voluntary movement of limbs, treatment with ventilator support for breathing, rehydration, and blood pressure control were continued.On (b)(6) 2023, repeat cranial ct revealed edema around the hematoma, and the dosage of dehydrating medication was increased.On (b)(6) 2023, ct re-examination showed there was still an intracranial hematoma.Treatment continued.On (b)(6) 2023, heparin sodium injection (0.2 ml.Subcutaneous, bid) was administered.On (b)(6) 2023, the patient was in sedated and analgesic status.Physical examination: reactive to light, muscle strength grade 4 in the right limb and grade 0 in the left limb.On (b)(6) 2023, heparin sodium injection (0.2 ml, subcutaneous, bid) was discontinued.On (b)(6) 2023, the state of sedation and analgesia was discontinued.Physical examination: drowsiness, could be awakened as instructed, slightly high muscle tone of the extremities, the muscle strength of the left upper extremity grade 1, the muscle strength of the left lower extremity grade 0, the muscle strength of the right upper extremity grade 4, and the muscle strength of the right lower extremity grade 3.On (b)(6) 2023, mri: the patient had no significant lesions in the brainstem.From (b)(6) 2023 to (b)(6) 2023, physical examination: clear mind, compliant doctor's advice, muscle strength as before.On (b)(6) 2023, the patient discharged with improvement.Discharge physical examination: clear mind, compliant doctor's advice, tracheotomy status¿.¿both pupils were unequal, left upper limb muscle strength grade 2, left lower limb muscle strength grade 0, right limb muscle strength grade 4.The patient was discharged from the hospital and continued rehabilitation.Discharged with medications: aspirin, atorvastatin.Considering that the patient still had sequelae of cerebral hemorrhage, and rehabilitation was performed after discharge, so this cerebral hemorrhage sae follow-up report was submitted.Permanent impairment of body structure or body function was incorrectly checked in the initial report sae classification and unchecked in this update as requiring hospitalization or prolonged hospitalization.The patient was discharged from xuanwu hospital on (b)(6) 2023 and then transferred to beijing boai hospital for rehabilitation.The investigator viewed the patient's bleeding foci according to the (b)(6) 2023 head ct image and found that it was completely absorbed.The patient's current symptoms were limb weakness, blurred vision, slurred speech, and forgetfulness.The patient was undergoing rehabilitation training, daily acupuncture treatment, upper limb training, and lower limb standing exercise.Considering that the patient's cerebral hemorrhage was in the recovery period and the patient's symptoms were recovering, the follow-up report of sae is submitted.¿ correction: measures taken: other: tracheal intubation, ventricular puncture and drainage, incorrectly checked, now changed to: medication, hospitalization for surgery, nonpharmaceutical treatment¿.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1.Patient identifier (b)(6).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.

Manufacturer Narrative

Product complaint # (b)(4).Section e1.Initial reporter phone: (b)(6).Complaint conclusion: as reported via the (b)(4) study in china, a 52-year-old male ((b)(4)) who underwent vascular stent placement with an enterprise2 4mmx16mm no tip (encr401600, (b)(6)) reconstruction device on (b)(6) 2023, on the same day as the surgical procedure, the patient experienced a cerebral hemorrhage, which was assessed by the pi as severe in severity, unrelated to the study device, but possibly unrelated to the surgical procedure.There was no device deficiency, there was no ischemic stroke, but the cerebral hemorrhage was symptomatic.The outcome of the event was ¿symptom resolved¿.The event required or prolonged inpatient hospitalization.¿intraoperative imaging on (b)(6)2023 revealed severe stenosis of the c6 segment of the right internal carotid artery with a stenosis of approximately 83%.The patient was confirmed to be enrolled and a test stent was implanted, with postoperative stenosis of less than 40%, the stent having completely covered the lesion.The patient returned to the ward safely without complaining of discomfort.On (b)(6) 2023, after the operation, the patient suddenly had a headache, accompanied by irritability and slurred speech.Rescue measures: immediately stop the use of tirofiban, and urgently check the bedside ct, suggesting ventricular hemorrhage, and was transferred to the icu, where the patient was intubated and put on a ventilator for assisted respiration.The lateral ventricle was punctured and drained.The cause of the hemorrhage was considered to be the restoration of the diameter of the stenotic vessel after stent angioplasty and the dramatic increase in blood flow in a short period of time leading to cerebral hemorrhage, which was the result of reperfusion injury.It was judged to be not related to investigational product and possibly unrelated to the surgery.On (b)(6)2023, aspirin enteric-coated tablets (100mg, qd) were given.From (b)(6) 2023, the patient was in sedated and analgesic status.Physical examination: unresponsive to light, no voluntary movement of extremities, intracerebroventricular urokinase injection given.From (b)(6)2023, the patient was in sedated and analgesic status¿.¿physical examination: reactive to light, no voluntary movement of limbs, treatment with ventilator support for breathing, rehydration, and blood pressure control were continued.On (b)(6)2023, repeat cranial ct revealed edema around the hematoma, and the dosage of dehydrating medication was increased.On (b)(6)2023, ct re-examination showed there was still an intracranial hematoma.Treatment continued.On (b)(6)2023, heparin sodium injection (0.2 ml.Subcutaneous, bid) was administered.On(b)(6)2023, the patient was in sedated and analgesic status.Physical examination: reactive to light, muscle strength grade 4 in the right limb and grade 0 in the left limb.On (b)(6)2023, heparin sodium injection (0.2 ml, subcutaneous, bid) was discontinued.On (b)(6)2023, the state of sedation and analgesia was discontinued.Physical examination: drowsiness, could be awakened as instructed, slightly high muscle tone of the extremities, the muscle strength of the left upper extremity grade 1, the muscle strength of the left lower extremity grade 0, the muscle strength of the right upper extremity grade 4, and the muscle strength of the right lower extremity grade 3.On (b)(6)2023, mri: the patient had no significant lesions in the brainstem.From (b)(6)2023 to (b)(6)2023, physical examination: clear mind, compliant doctor's advice, muscle strength as before.On (b)(6)2023, the patient discharged with improvement.Discharge physical examination: clear mind, compliant doctor's advice, tracheotomy status¿.¿both pupils were unequal, left upper limb muscle strength grade 2, left lower limb muscle strength grade 0, right limb muscle strength grade 4.The patient was discharged from the hospital and continued rehabilitation.Discharged with medications: aspirin, atorvastatin.Considering that the patient still had sequelae of cerebral hemorrhage, and rehabilitation was performed after discharge, so this cerebral hemorrhage sae follow-up report was submitted.Permanent impairment of body structure or body function was incorrectly checked in the initial report sae classification and unchecked in this update as requiring hospitalization or prolonged hospitalization.The patient was discharged from (b)(6) hospital on (b)(6)2023 and then transferred to (b)(6) hospital for rehabilitation.The investigator viewed the patient's bleeding foci according to the (b)(6) 2023 head ct image and found that it was completely absorbed.The patient's current symptoms were limb weakness, blurred vision, slurred speech, and forgetfulness.The patient was undergoing rehabilitation training, daily acupuncture treatment, upper limb training, and lower limb standing exercise.Considering that the patient's cerebral hemorrhage was in the recovery period and the patient's symptoms were recovering, the follow-up report of sae is submitted.¿ correction: measures taken: other: tracheal intubation, ventricular puncture and drainage, incorrectly checked, now changed to: medication, hospitalization for surgery, nonpharmaceutical treatment¿.The device remains implanted; therefore, no further investigation can be performed.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.Cerebral hemorrhage 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/ malfunctions related to the device, as the device performed as intended.The pi assessed the event as unrelated to the study device, but possibly unrelated to the surgical procedure.However, the relationship between the enterprise 2 device and the reported event of ¿cerebral hemorrhage¿ cannot be excluded.Therefore, this event will be conservatively reported, with an awareness date of 20-jul-2023, to the us fda under criteria 21 cfr 803 with the classification of ¿serious injury¿.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received on 01-nov-2023.Summary: on 01-nov-2023, a follow-up report regarding the adverse event of ¿cerebral hemorrhage¿ (which was assessed by the pi as severe in severity, unrelated to the study device, but possibly unrelated to the surgical procedure) was received.Per the reported update, a head mri, taken on (b)(6) 2023, showed that the cerebral hemorrhage in the right frontal lobe and basal ganglia area was in the recovery phase.The report also states the residual symptoms of limb weakness, speech difficulty, and blurred vision, are sequelae of the cerebral hemorrhage, and the patient's condition is stable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM 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 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17548304
• MDR Text Key: 321148329
• Report Number: 3008114965-2023-00583
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401600
• Device Lot Number: 7469261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male