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 Problem Ischemia Stroke (4418)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported via the icad study in china, a 70-year-old female patient (b)(6) who underwent vascular stent placement with an unknown enterprise ii vascular reconstruction device on (b)(6) 2022, experienced lacunar cerebral infarction on (b)(6) 2022.The principal investigator (pi) assessed this event as mild in severity, possibly not related to the study device, but possibly related to the surgical procedure.The event is still ongoing.No device deficiencies were reported.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received on 09-dec-2022.Summary of additional information provided: the study device was an enterprise2 4mmx16mm no tip (enci401600/6920551).After this operation, there was a new lacunar infarction in the right temporal lobe, frontal parietal cortex, and basal ganglia.The researchers considered that it might be caused by intraoperative procedures, such as angiography and bulbar dilation.The patient¿s medical history includes a ct on (b)(6) 2022, which showed bilateral paraventricular lacunar infarction.On (b)(6), an mri showed a new infarction in the right lateral ventricle.On (b)(6), an mri showed right lateral ventricle infarction.The adverse event was not treated and it¿s still under follow-up and has not been resolved.Section e1.Initial reporter phone: (b)(6).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).Complaint conclusion: as reported via the icad study in china, a 70-year-old female patient (b)(6) who underwent vascular stent placement with an enterprise2 4mmx16mm no tip (enci401600/6920551) on (b)(6) 2022, experienced lacunar cerebral infarction on (b)(6) 2022.The principal investigator (pi) assessed this event as mild in severity, possibly not related to the study device, but possibly related to the surgical procedure.The event is still ongoing.No device deficiencies were reported.Additional information received indicated that after this operation, there was a new lacunar infarction in the right temporal lobe, frontal parietal cortex, and basal ganglia.The researchers considered that it might be caused by intraoperative procedures, such as angiography and bulbar dilation.The patient¿s medical history includes a ct on (b)(6) 2022, which showed bilateral paraventricular lacunar infarction.On (b)(6) an mri showed a new infarction in the right lateral ventricle.On may 27, an mri showed right lateral ventricle infarction.The adverse event was not treated and it¿s still under follow-up and has not been resolved.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 infarction is a known potential adverse event associated with the use of the enterprise ii device and is listed in the instructions for use (ifu) as such.There are patient, procedural, and pharmacological factors that may have contributed with no indication of a device malfunction or defect.There is no evidence to suggest that the event of ¿lacunar cerebral infarction¿ was related to the use of the enterprise ii vascular reconstruction device.However, the relationship between the enterprise ii device and the reported event of ¿cerebral infarction¿ cannot be excluded as the pi assessed the event as possibly not related to the study device.Therefore, the event will be conservatively reported to the fda 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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

(b)(4).Section b5: additional information received on 19-jul-2023.On 27-jul-2022, the patient experienced the adverse event of ¿new onset lacunar cerebral infarction¿.The event was assessed by the pi as mild in severity, possibly unrelated to the study related device but possibly related to the surgery.The event is still ongoing.No device deficiencies were reported.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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15788741
• MDR Text Key: 303568681
• Report Number: 3008114965-2022-00749
• 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,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• 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: 6920551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• 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: 73 YR
• Patient Sex: Male