MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

Patient Problems High Blood Pressure/ Hypertension (1908); Stenosis (2263)

Event Date 07/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section a1.Patient identifier:(b)(6).D.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.The device remains implanted, therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.An assessment from the medical safety officer (mso) was received on (b)(6) 2024.Summary: regarding the adverse event of ¿in-stent restenosis of the left internal carotid artery (severe),¿ this event was thoroughly discussed with the mso on (b)(6) 2024.Per the mso, ¿this event occurred within the therapeutic lifetime of the device this should be considered as a possible adverse event relating to our device.Device involvement cannot be excluded.¿ per the additional information received on (b(6) 2023, the patient experienced the event of ¿in-stent restenosis of the left internal carotid artery (severe),¿ which was assessed as possibly unrelated to the study device.There were no alleged quality issues related to the device, as the device performed as intended.However, the correlating relationship between event to used device cannot be ruled out entirely and the event occurred within the one-year device therapeutic lifetime.Additionally, the event describes the in-stent stenosis as severe, therefore it is clinically reasonable to assume that an intervention would be provided in the case of severe stenosis of a cerebral artery, such as intravenous anticoagulation medications.The outcome is recorded as ¿symptoms ongoing,¿ therefore the extent of the event is unknown.Based on this information and the assessment of the pi and mso, the event of ¿in-stent restenosis of the left internal carotid artery (severe)¿ does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury,¿ with an awareness date of (b)(6) 2023.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, a 67-year-old female patient (b)(6) who underwent vascular stent placement with an unknown enterprise ii vascular reconstruction device, experienced the event of ¿in-stent restenosis of the left internal carotid artery (severe),¿ on (b)(6) 2023, which became known to the site on (b)(6) 2023.The pi assessed this event as not serious, moderate in severity, and as possibly unrelated to the study device and unrelated to the surgery.The event was not an unanticipated adverse device effect (uade), and there were no device deficiencies related to the event.The event was treated with medication, but did not result in prolonged hospitalization, a fatal illness/injury, nor was it classified as an ischemic or hemorrhagic stroke.The device remains implanted for continued use.The outcome is recorded as ¿ongoing symptoms,¿ with no end date listed.

Manufacturer Narrative

(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 4MMX23MM
• 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: 18495043
• MDR Text Key: 332728255
• Report Number: 3008114965-2024-00031
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6920558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female