MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCI401612

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1.(b)(6).Section d3: the product catalog and lot numbers were not reported; udi unavailable.Section e1: initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.

Event Description

As reported via the icad study in china (b)(4), a 54-year-old female patient (subject#: (b)(6), with an unknown medical history underwent vascular stent placement on (b)(6) 2023 with an enterprise ii vascular reconstruction device (unkenterprise2 unknown catalog / unknown lot).Per initial information received the patient experienced ¿hemorrhage in the brain¿ on the same day of the procedure.The principal investigator (pi) assessed this event as a serious adverse event, severe, unrelated to the study device, possibly unrelated to the surgical procedure and not an unanticipated adverse device effect (uade).The event is noted to be persistent with the outcome value entered as ¿persistence of symptoms¿ and the end date value as blank.The patient was medically treated (see description of the event below).The event did result in a required/ prolonged inpatient hospitalization, with no permanent impairment in body function / structure.The subject was not withdrawn from the trial and there was continued use of the study device.No ischemic stroke or symptomatic cerebral hemorrhage was reported in relation to the event.There was no report of device deficiency.Per description of the event, ¿on (b)(6) 2023, the patient complained of sudden slurred speech, right limb weakness, and cognitive impairment for more than one month, and was admitted to the (b)(6) group 2 with carotid artery stenosis".¿intraoperative angiography on (b)(6) 2023 showed severe stenosis of the c7 segment of the left internal carotid artery (ica), with a stenosis rate of about 85%¿.¿during the operation, a ton-bridge 2.0*10 mm balloon was placed along the microcatheter at the stenosis of the c7 segment of the left ica to name the pressure and expand slowly¿.¿the balloon system was withdrawn.The enterprise 2 4 x 16 mm stent was inserted, and the angiographic residual stenosis was 26%, and the stent had completely covered the lesion¿.¿re-examination of the head ct showed subarachnoid hemorrhage in the left parietal lobe and left temporal lobe hemorrhaged, and the operation was ended¿.¿postoperatively, the patient was sedated and was given analgesic, tracheal intubation was performed to assist breathing, and the patient was transferred to the neurosurgery icu with endotracheal intubation to monitor intracranial pressure.Aspirin and ticagrelor dual antiplatelet aggregation therapy was suspended.¿ ¿on (b)(6) 2023, a re-examination of the head ct showed that the left temporal lobe hemorrhage was more than before.Continued sedation and analgesia.Controlled blood pressure within 110 mmhg.Ecg monitoring showed: bp: 110/69 mmhg.At 11 o'clock, the amount of bleeding in head ct was very similar to that of yesterday.Continued analgesia and sedation, added aspirin nasal feeding, mannitol to reduce intracranial pressure, and closely observed vital signs¿.¿on (b)(6) 2023, a re-examination of head ct showed no new bleeding¿.It was further stated that ¿considering that the cerebral hemorrhage is related to reperfusion injury, it is judged that it is unrelated to the device and is possibly unrelated to the operation¿.¿on (b)(6) 2023, re-examination of the head ct showed no new hemorrhage or infarction¿.¿on (b)(6) 2023, the patient's consciousness was improving, the patient's sight could be tracked, and the patient partially complied with the instructions.The patient could move the left side of the limbs, could lightly move the right side of the lower limb, and had cough reflex.Dexamethasone (5 mg qn) was added statically and nebulized¿.¿on (b)(6) 2023, the patient had stable breathing, good cough reflex, and clear consciousness.The tracheal extubation was performed, and there was no dyspnea after extubating.Physical examination: the left side of the limbs can be moved, but the right side of the limbs cannot.The patient can answer the questions correctly.Ticagrelor (90 mg nasogastric feeding qd) dual anti-platelet aggregation therapy was added, and the rest of the treatment was the same as before¿.¿on (b)(6) 2023, the patient had clear consciousness.Head ct: compared with the plain scan of the head ct on (b)(6)2023, no new hemorrhage was found.After repeated evaluations, the patient's head ct showed no significant increase in hemorrhage and gradual absorption.The patient was discharged and was asked to continue rehabilitation out of hospital.¿ additional event information was received on (b)(6) 2023.Summary of relevant information provided: it was clarified that the ¿parenchymal hemorrhages considered reperfusion injury and the ct also showed subarachnoid hemorrhage.¿.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: additional information received on 13-jul-2023.Product code and lot number for the enterprise stent provided.Enterprise 2 4mmx16mm (enci401612/7126524).Section e1.Initial reporter phone: (b)(6).The device was implanted; therefore, no further investigation can be performed.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 and subarachnoid bleeding are known complications associated with the use of the enterprise ii vascular reconstruction device and are mentioned in the instructions for use (ifu) as such.Clinical and procedural factors, including vessel characteristics, device selection, device interaction, and operator technique, may have contributed rather than the design or manufacture of the device.Per pi assessment, the cause of the parenchymal cerebral hemorrhage was caused by reperfusion injury.However, given the timeline between the procedure/device usage and the reported adverse event of subarachnoid hemorrhage, and although there was no reported device performance issue/ malfunction, the event the event will be conservatively reported to the us fda mdr under 21 cfr 803 with the classification of ¿serious injury¿; moreover, the patient required medication and prolonged hospitalization.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was received on 08-sep-2023.Summary of the information provided: on (b)(6) 2023, the patient experienced the event of ¿hemorrhage brain¿; this information was previously reported on 08-jun-2023.The additional information included a follow-up report regarding this event.The information was reported as such: ¿it was learned on (b)(6) 2023 that the patient was hospitalized for rehabilitation at beijing fengtai you'anmen hospital from 12-apr-2023 to (b)(6) 2023.When the patient was admitted to the hospital, the muscle strength of the limbs was grade 4, and the patient demonstrated bilateral finger-to-nose coordination.The heel, knee and shin are not stable, and the rest are normal.According to the head ct image on (b)(6) 2023, the investigator judged that the hemorrhagic focus had been completely absorbed.The patient is currently undergoing rehabilitation at home without discomfort.This report is a follow-up report of cerebral hemorrhage¿.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM
• 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 ; 3035526892
• MDR Report Key: 17217287
• MDR Text Key: 318038076
• Report Number: 3008114965-2023-00437
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCI401612
• Device Lot Number: 7126524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female