MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

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

Patient Problem Restenosis (4576)

Event Date 07/08/2022

Event Type  Injury  

Event Description

Event details: event date: (b)(6) 2022, date of study surgery: (b)(6) 2021, event description: in-stent stenosis.Patient details: patient identifier: (b)(6), sex: female, age (at time of consent): 68 years.Additional patient details: severity: moderate.Is this a serious adverse event?: no.#1 leading to death: no.Date of death(dd-mmm-yyyy): blank.#2 life-threatening diseases or injuries: no.#3 permanent damage of body structure or function: no.#4 requiring hospitalization or prolonged hospitalization: no.#5 requiring medications or surgical intervention to avoid permanent damage of body structure or function: no.#6 lead to fetal distress, fetal death or congenital malformation or birth defect.: no.Relationship with study device: possibly related.Relationship with study procedure: unrelated.Relationship with dual antiplatelet therapy: possibly related.Outcome: recovering / resolving.Action taken#1 no action taken: no.Action taken#2 medical treatment - please record/update in page "previous and concomitant medication": no.Action taken#3 check/evaluation: yes.Action taken#4 intravascular interventional treatment: no.Action taken#5 surgical treatment: no.Action taken#6 other: no.If other, please specify: blank.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Patient identifier- (b)(6).Initial reporter: the customer's contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Device manufacture date: not available at the time of the report.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 4.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.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information was received on 19-aug-2022 indicated that per the physician¿s assessment the cause of stenosis is more likely to be the patient's ¿personal physical factors¿.The patient is currently recovering/healing without any treatment.There was no stroke or thrombus.The patient is in good condition currently.Complaint conclusion: as reported via the empower study, a 68-year-old female (subject (b)(6)) with a history of a mass on the right neck underwent stent-assisted coil embolization of an unruptured wide-necked internal carotid artery (ica) saccular aneurysm on (b)(6) 2021.The saccular aneurysm had the following dimensions: maximum aneurysm diameter of 5.2mm and neck width of 4.5mm.The parent vessel diameter was 3.7mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 no tip vascular reconstruction device (vrd) (encr402300/5964704) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.The immediate post-procedure assessment showed raymond-roy's score of class i: complete obliteration.The routine neurological examination was normal prior to discharge on (b)(6) 2021, which revealed a hunt & hess grade 0 and a modified rankin scale (mrs) score of 0.A 30-day follow-up visit was performed via phone on (b)(6) 2021.The dsa examination was planned for 180 days after surgery.A 180-day follow-up was performed on (b)(6) 2021 and (b)(6) 2021.The routine neurological examination was normal and revealed a modified rankin scale (mrs) score of 0, a hunt & hess grade 0, and a raymond-roy's score of class i: complete obliteration.Dsa performed on that day showed no signs of rupture, hemorrhage, in-stent stenosis, or in-stent thrombosis.The patient¿s one (1) year follow-up was performed on (b)(6) 2022 and (b)(6) 2022.During this visit, the patient answered ¿yes¿ to whether in-stent thrombosis had occurred.The routine neurological examination was normal, with a modified rankin scale (mrs) score of 0, a hunt & hess grade of 0, and raymond-roy's score of class i: complete obliteration.However, dsa performed on (b)(6) 2022 showed in-stent stenosis.The principal investigator assessed this event as moderate in severity, not serious, possibly related to the study device, unrelated to the study procedure, and possibly related to the dual antiplatelet therapy.The event is resolving, and the patient is recovering.The patient was not treated for the event.Additional information was received on 19-aug-2022 indicated that per the physician¿s assessment the cause of stenosis is more likely to be the patient's ¿personal physical factors¿.The patient is currently recovering/healing without any treatment.There was no stroke or thrombus.The patient is in good condition currently.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.Stenosis is a known complication associated with the use of the enterprise 2 vascular reconstruction device and is mentioned in the instructions for use (ifu) as such.The device performed as intended and no new patient consequences have occurred related to the use of the device.There is no evidence of a study device defect or quality issue.However, the principal investigator assessed the event of in-stent stenosis as possibly related to the study device, unrelated to the study procedure, and possibly related to the dual antiplatelet therapy.Therefore, this event is considered serious and mdr reportable.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.

• Brand Name: ENTERPRISE2 4MMX23MM 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15183692
• MDR Text Key: 297437852
• Report Number: 3008114965-2022-00530
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: ENCR402300
• Device Lot Number: 5964704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• 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: 68 YR
• Patient Sex: Female