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

Catalog Number ENCI402312

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

Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 10/18/2023

Event Type  Injury  

Event Description

As reported via the icad study (cnv202003) in china, a 76-year-old male (subject 0413) underwent a vascular stent placement on (b)(6) 2023 using an unknown cerenovus enterprise 2 vascular reconstruction device (catalog / lot# unknown).Per the event description, on (b)(6) 2023 the patient experienced the event of a "brain infarction." the principal investigator assessed this event as not serious, moderate in severity, and as possibly unrelated to the study device and unrelated to the surgery.The ischemic stroke was classified as a ¿symptomatic intracranial arterial stenosis in the blood vessel."the event was not unanticipated.The event was treated with medication but did not result in a fatal illness or injury, prolonged hospitalization, or death.No device deficiency was reported, and the device remains implanted in the patient for continued use.The outcome is recorded as "symptoms ongoing.".

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d3 ¿ the product catalog and lot numbers were not reported; udi unavailable.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Regarding the event of "brain infarction", a cerebral infarction is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device and is mentioned in the instructions for use (ifu) as stroke.There were no alleged quality issues related to the device, as the device performed as intended.The event of a ¿brain infarction¿ was assessed by the pi as possibly unrelated to the study device, but unrelated to the surgical procedure.Since a cerebral infarction is considered a serious injury and the relationship of the enterprise2 stent to the reported event cannot be excluded, the event does meet us fda reporting criteria under 21 cfr 803 with a classification of "serious injury." 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.

Manufacturer Narrative

Product complaint #(b)(4).Additional information was received on 14-dec-2023.Summary: a correction regarding the used device was received; the correct product code is enci402312.

Manufacturer Narrative

Product complaint #: (b)(4).Additional device information was received on 14-nov-2023.Summary: the used device was an enterprise 2.4mmx23mm (encr402312/ 6920558) stent.Complaint conclusion: as reported via the icad study ((b)(6)) in china, a 76-year-old male (subject (b)(6)) underwent an vascular stent placement on (b)(6) 2023 using an enterprise2 4mmx23mm (encr402312, 6920558).Per the event description, on (b)(6) 2023 the patient experienced the event of a ¿brain infarction.¿ the principal investigator assessed this event as not serious, moderate in severity, and as possibly unrelated to the study device and unrelated to the surgery.The ischemic stroke was classified as a ¿symptomatic intracranial arterial stenosis in the blood vessel.¿ the event was not unanticipated.The event was treated with medication but did not result in a fatal illness or injury, prolonged hospitalization, or death.No device deficiency was reported, and the device remains implanted in the patient for continued use.The outcome is recorded as ¿symptoms ongoing.¿ 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.Regarding the event of ¿brain infarction¿, a cerebral infarction is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device and is mentioned in the instructions for use (ifu) as stroke.There were no alleged quality issues related to the device, as the device performed as intended.The event of a ¿brain infarction¿ was assessed by the pi as possibly unrelated to the study device, but unrelated to the surgical procedure.Since a cerebral infarction is considered a serious injury and the relationship of the enterprise2 stent to the reported event cannot be excluded, the event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ 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

Product complaint # (b)(4).Additional/modified information was received on 15-mar-2024.Summary: regarding the adverse event of ¿brain infarction,¿ the pi¿s assessment was updated from ¿possibly unrelated to the study device and unrelated to the surgery¿ to ¿unrelated to the study device and unrelated to the surgery.¿ 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/modified information was received on 30-apr-2024.Summary: regarding the adverse event of ¿brain infarction,¿ the relationship of event to the study device was updated from ¿unrelated¿ to ¿possibly related.¿ this modified information has been reviewed.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 b3: additional/modified information was received on 15-may-2024.Summary: regarding the adverse event of ¿brain infarction,¿ the ¿date of start¿ was updated from ¿17-oct-2023¿ to ¿18-oct-2023.¿ 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18121696
• MDR Text Key: 328000692
• Report Number: 3008114965-2023-00831
• 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,Followup
• Report Date: 05/22/2024

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: ENCI402312
• Device Lot Number: 6920558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 12/14/2023; 03/15/2024; 04/30/2024; 05/15/2024
• Supplement Dates FDA Received: 11/27/2023; 12/29/2023; 03/26/2024; 05/02/2024; 05/22/2024
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male