MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

Patient Problem Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.Section 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 e.1: the initial reporter facility name, address, and the name, phone and email address of the initial reporter are not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Restenosis of stented segment is a well-known potential adverse event following stent implantation and is listed in the enterprise stent vascular reconstruction device instructions for use (ifu) as such.Experience with stent implants indicates that there is a risk of stenosis.Patient, procedural, and pharmacological factors may have contributed, however, with the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the reported event.There are patient, procedural, and pharmacological factors that may have contributed with no indication of a device malfunction or defect.Nevertheless, since the severity and time of occurrence of the stenosis is not clear (unknown if it has occurred peri-procedural use of the device) and the ae necessitated medication, this event is usfda reportable under 21 cfr 803 with a 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 for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The event was reported via the icad study in china.The 55-year-old male patient underwent a vascular stent placement procedure on (b)(6) 2022, and an enterprise 2 stent (catalog / lot# unknown) was implanted.It was reported that the patient experienced a right middle cerebral artery (mca) stent restenosis on an unknown date.The principal investigator (pi) assessed this adverse event as severe, not a serious adverse event, unrelated to the study device, possibly unrelated to the surgery, and not an unanticipated adverse event effect (uade).The event is noted to be persistent with the outcome value entered as ¿ongoing symptom.¿ the patient was treated with medication (unspecified name and dosage).No non-drug therapy, or inpatient surgery was necessary.The event did not result to a required/ prolonged inpatient hospitalization, or permanent impairment in body function/ structure.The subject was not withdrawn from the trial and there was continued use of the study device.No ischemic stroke or symptomatic cerebral hemorrhage was reported in relation to the event.No device deficiency was reported.On 07-jun-2023, modified additional event information was received.The information indicated that the patient also experienced a severe stenosis of the a1 segment of the right anterior cerebral artery (aca) on an unknown date.The pi assessed the event as severe, not a serious adverse event, unrelated to the study device, unrelated to the surgery, and not an unanticipated adverse device effect (uade).The event is noted to be persistent with the outcome value entered as ¿ongoing symptom.¿ the event did not result to a required/ prolonged inpatient hospitalization, or permanent impairment in body function/ structure.The subject was not withdrawn from the trial and there was continued use of the study device.No ischemic stroke or symptomatic cerebral hemorrhage was reported in relation to the event.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 18-jun-2023 and 19-jun-2023.[additional information]: on 18-jun-2023, additional information was received.The information indicated that the study device used was a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600 / 6920551).Six (6) months after the procedure, the patient returned to the hospital on (b)(6) 2023, for re-examination via digital subtraction angiography (dsa), and re-stenosis was observed.The patient was asymptomatic and the event was found by re-examination in the hospital as required by the [study] protocol.On 19-jun-2023, additional information was received.The catalog and lot number of the study device was changed from 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600 / 6920551) to 4mm x 23mm enterprise 2 stent (encr402312 / 6920558).Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot: 6920558.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: UNKENTERPRISE2
• 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 ; 303552-689
• MDR Report Key: 17140716
• MDR Text Key: 317300055
• Report Number: 3008114965-2023-00378
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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?: Yes
• Date Manufacturer Received: 06/18/2023
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male