MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

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

Patient Problem Restenosis (4576)

Event Date 11/23/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / 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.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.Arterial stenosis is a known potential complication associated with the use of the enterprise 2 device and is listed in the instructions for use (ifu) as such.There were no alleged performance issues/malfunctions related to the device, as the device performed as intended.The pi assessed the event of ¿in-stent occlusion of the left middle cerebral artery¿ as possibly unrelated to the device and possibly unrelated to the surgical procedure.Per section 4.10 of the enterprise stent clinical evaluation report (cer), the therapeutic lifetime of the enterprise stent is one year.Although there may have been patient, procedural, and pharmacological factors that may have contributed to the event, with no indication of a device malfunction or performance issue, the correlating relationship of the event to the device cannot be ruled out, as the event occurred approximately 148 days after the procedure, within the therapeutic lifetime of the device.Additionally, although no specific intervention is stated, the event was deemed a severe adverse event and it is clinically reasonable to assume an intervention would be provided in the case of an occlusion at/near the stent site.Based on this information, this event meets us fda reporting criteria under 21 crf 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 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.The 35-year-old male patient was admitted to the hospital on (b)(6) 2022 due to severe stenosis of the left middle cerebral artery.On (b)(6) 2022, he signed the ¿intracranial stent implantation in patients with severe symptomatic atherosclerotic intracranial artery stenosis (cerenovus enterprise 2 intracranial stent): a chinese multicenter, prospective, single-group target value study" informed consent form.On (b)(6) 2022, the patient underwent the vascular stent placement procedure.Intraoperative angiography showed severe stenosis of the left middle cerebral artery, with a stenosis rate of about 78.4%, which met all the inclusion criteria and did not meet any exclusion criteria.The 4.0mm x 23mm enterprise 2 stent (catalog and lot# unknown) was implanted during the surgery, and the residual stenosis was about 33.6% immediately after the surgery, and the stent had completely covered the lesion.The patient returned to the ward safely and was discharged on (b)(6) 2022.On (b)(6) 2022, when the patient was contacted for digital subtraction angiography (dsa) expense reimbursement, it was informed that the patient was hospitalized and treated in the department of cardiovascular medicine on (b)(6) 2022 due to a history of patent foramen ovale (pfo) (without clinical symptoms).On (b)(6) 2022, the patient underwent a successful procedure to close the pfo.The patient returned to the ward.The principal investigator (pi) assessed this event as moderate in severity and as unrelated to the study device and unrelated to the surgical procedure.The event required an in-patient surgery and prolonged hospitalization.The outcome is recorded as ¿symptom resolved without sequelae¿ with an end date of on (b)(6) 2022.On (b)(6) 2022, the patient had no discomfort on the first day after the surgery and was discharged on the same day.The serious adverse event (sae) was caused by the patent foramen ovale in the previous medical history; therefore, it was judged to have nothing to do with the surgery or the study device, and the severity was moderate.This report is the initial and summary report.On 13-dec-2023, additional information was received.It was reported that the patient experienced an in-stent occlusion of the left middle cerebral artery on (b)(6) 2022.The pi assessed this event as a severe adverse event that was possibly unrelated to the study device and possibly unrelated to the surgical procedure.The event was not medically treated.The outcome is recorded as ¿symptoms ongoing¿ with no end date listed.The event did not result in prolonged inpatient hospitalization, or permanent impairment in body function/ structure.The subject was not withdrawn from the trial and there was continued use of the study device.The device remains implanted and is thus not available for evaluation.No device deficiencies were reported.Based on the additional information received on 13-dec-2023, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿serious injury.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to make a correction to the awareness date of the adverse event that was reported and submitted in the initial medwatch report mwr-15122023-0001536071 on 15-dec-2023.The initial medwatch report captured the incorrect awareness date of 14-dec-2022 in section g.3.This resulted in the incorrect report submission due date of the initial medwatch report.The correct awareness date is 13-dec-2023.The correct report submission due date is 12-jan-2024.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.The awareness date (section g.3) in the initial medwatch was incorrectly documented as 14-dec-2022.This resulted in the wrong report submission due date of 13-jan-2023 captured in the initial medwatch report.The correct awareness date is 13-dec-2023.This supplemental medwatch report has the correct awareness date documented in section g.3.The correct report submission due date of the initial medwatch report is 12-jan-2024.

• Brand Name: UNKENTERPRISE2
• 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
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18340070
• MDR Text Key: 330666805
• Report Number: 3008114965-2023-00960
• 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,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Male