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 High Blood Pressure/ Hypertension (1908)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Event information: whether it is an sae: ae.Date of start (dd/mmm/yyyy): on (b)(6) 2022.Date of record: on (b)(6) 2022 1:23:16pm.Place: (b)(6).Date of signing informed consent form (dd/mmm/yyyy): on (b)(6) 2022.Date of surgery (dd/mmm/yyyy): on (b)(6) 2022.Name of adverse event: stress blood pressure increased.Subject information: subject no.: (b)(6).Gender: male.Age: 55 years old.Detailed ae information: date of awareness (dd/mmm/yyyy): on (b)(6) 2022.Severity: moderate.Relationship to study related device?: unrelated.Relationship to surgery? : possibly related.Whether it is an unanticipated adverse device effect (uade)? (if yes, please report to the sponsor and local ethics committee within 24 hours): no.Whether it is device deficiency: no.Action taken with study device: continued use.< b > additional therapeutic measures < /b > none: no.Medication: yes.Non-drug therapy: no.Inpatient surgery: no.Other: no.Is the subject withdrawn from the trial due to an adverse event? : no.Whether it is persistent: no.Outcome: symptoms disappeared without sequelae.End date (dd/mmm/yyyy): on (b)(6) 2022.Whether it is ischemic stroke: no.If ischemic stroke, please select the classification: blank.Whether it is symptomatic cerebral hemorrhage: no.Whether it is all-cause death: no.If all-cause death, please select the classification: blank.< b > sae classification < /b > cause death: no.Fatal illness or injury: no.Require or prolong inpatient hospitalization: no.Permanent impairment of body structure or body function: no.Take therapeutic measures to avoid permanent impairment of body structure or body function: no.Cause fetal distress, fetal death or congenital anomaly, congenital defect: no.Other: no.Please specify the sae 1:blank.Please specify the sae 2: blank.Please specify the sae 3:blank.

Manufacturer Narrative

Product complaint#: (b)(4).Patient identifier: (b)(6).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.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, b7, d1, d4, e1, e3, g3, g6, h4, h6 and h10.Section b5: additional information was received on 10-jan-2023 providing the study device catalog and lot number.The physician believes that the hypertension was caused by the operation.The patient does not have a medical history of hypertension.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.Per the principal investigator¿s assessment, the event was not related to the study device but possibly related to the surgery.Therefore, this event no longer meets mdr reporting criteria and no supplemental reports will be forthcoming for this event.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16108261
• MDR Text Key: 306792021
• Report Number: 3008114965-2023-00008
• 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
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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
• Date Manufacturer Received: 01/10/2023
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male