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 Restenosis (4576)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).Section a1.Patient identifier: (b)(6).The device remains implanted and is thus not available for evaluation.The lot number is not known; therefore, a device history record review cannot be completed.Per the additional information received on 19-dec-2023, the patient experienced the event of ¿severe in-stent restenosis,¿ which was assessed by the pi as possibly related to the study device.There were no alleged quality issues related to the used device, as the device performed as intended.There may have been patient, procedural, and pharmacological factors that contributed to the event; however, based on the assessment of the pi, the correlation between used device to the event of a severe in-stent restenosis cannot be ruled out.Additionally, although no specific intervention is stated, the event term describes the stenosis as severe, and it is clinically reasonable to assume an intervention would be provided in the case of an occlusion at/near the stent site.Based on this information, this event does meet us fda reporting criteria under 21 crf 803 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 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 (b)(4), a patient (subject#: (b)(6) underwent a vascular stent placement (unknown date) with enterprise 2 vascular reconstruction device (unkenterprise2).On (b)(6) 2023, the patient experienced the event of ¿severe in-stent restenosis.¿ the principal investigator (pi) assessed this event as not serious, mild in severity, and as possibly related to the study device and unrelated to the surgery.The event was not an unanticipated adverse device effect (uade), did not require or prolong inpatient hospitalization, was not classified as an ischemic stroke or symptomatic cerebral hemorrhage, and did not lead to death or fatal injury/illness.The event was not medically treated, and the outcome is recorded as ¿symptom ongoing.¿ there was no reported device deficiency related to the event and the device remains implanted for continued use.

Manufacturer Narrative

Product complaint # (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.Per the additional information received on 22-jan-2024, the patient was asymptomatic, and no intervention was performed for the event of ¿severe in-stent restenosis.¿ although the outcome of the event is recorded as ¿symptoms ongoing¿ on the clinical database, the additional information confirms there were no symptoms/neurological deficits.Based on this information, this event does not meet the definition of a serious injury, and thus, this event no longer meets us fda reporting criteria under 21 crf 803.The file will be re-reviewed if additional information is received at a later date.

• 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18475868
• MDR Text Key: 332493252
• Report Number: 3008114965-2024-00021
• 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,Health Professional
• Reporter Occupation: Physician
• 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: 01/09/2024
• 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: 01/23/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian