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

Catalog Number ENCR401612

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

Patient Problem Restenosis (4576)

Event Date 03/04/2024

Event Type  Injury  

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).Section e1 ¿ initial reporter: the initial reporter facility name was not reported.Section e1.Initial reporter phone: (b)(6).Arterial restenosis of stented segment is a known potential adverse event associated with the enterprise 2 vascular reconstruction device and is listed in the instructions for use (ifu) as such.The device performed as intended with no alleged quality issue.There may also be patient, procedural, and pharmacological factors that may have contributed to the infarction with no indication of a device malfunction or defect.Section 4.10 of the clinical evaluation report (cer) for the medical device says the therapeutic lifetime of the enterprise stent is one year.Although there may have been pharmacological factors that may have contributed to the event (such as anticoagulation medication interruption), 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, the event required a surgical intervention to preclude patient harm.Based on this information and the assessment of the pi, this event does meet 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 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.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)(6) subject # 0805, a 68-year-old female, underwent a vascular stent placement with an enterprise ii (enci401612/6920556) vascular reconstruction device on (b)(6) 2023.On 04-mar-2024, the patient experienced the event of ¿restenosis of left middle cerebral artery after stent implantation of the m1 segment,¿ which became known to the site on 06-mar-2024 and to the sponsor on 08-mar-2024.The principal investigator assessed this event as moderate in severity, and as possibly related to the study device, and possibly related to the surgical procedure.The event was not an unanticipated adverse device effect (uade).The event was not classified as an ischemic stroke or symptomatic cerebral hemorrhage.The event required an in-patient surgery but did not require prolong inpatient hospitalization.The event did not result in permanent impairment of body structure/body function nor fatal illness or injury.The outcome is recorded as ¿other: persistent symptoms,¿ with no end date listed.No device deficiencies were reported, and the device remains implanted for continued use.Additional/modified information was received on 17-mar-2024.Summary: regarding the adverse event of ¿restenosis of left middle cerebral artery after stent implantation of the m1 segment,¿ the following answer fields were modified: inpatient surgery: ¿yes¿ was updated to ¿no.¿ other: ¿no¿ was updated to ¿yes.¿ if other, please describe: ¿blank¿ was updated to ¿surgery is recommended.¿ additional/modified information was received on 25-mar-2024.Summary: regarding the adverse event of ¿restenosis of left middle cerebral artery after stent implantation of the m1 segment,¿ the outcome value of ¿other: persistent symptoms¿ was updated to ¿symptoms ongoing.¿ additional/modified information was received on 25-mar-2024.Summary: regarding the adverse event of ¿restenosis of left middle cerebral artery after stent implantation of the m1 segment,¿ the answer value for ¿action taken with study device¿ was updated from ¿not applicable¿ to ¿continue use.¿ additional information was received from the icad clinical study team on 27-mar-2024.Summary: regarding what the physician think caused or contributed to the event, it was stated, ¿the patient is taking medication according to the doctor's instructions (this patient has undergone drug gene testing analysis), which may be due to the increased risk of restenosis of the closed-loop stent.¿ the patient¿s baseline neurological status (including diagnosis or symptoms) was said to be, ¿admission chief complaint: right limb weakness for 1 month, aphasia for 13 days, dizziness for 3 days, fainting for 2 days.¿ the patient¿s neurological status after the event was ¿unobtainable.¿ the current status of the patient was said to be, ¿no symptoms occurred during this follow-up.¿ this additional information has been reviewed.No changes regarding the reportability determination nor coding were required.

Manufacturer Narrative

Product complaint#: (b)(4).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.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: 19012978
• MDR Text Key: 339038360
• Report Number: 3008114965-2024-00358
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401612
• Device Lot Number: 6920556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female