MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the 4mm x 30mm enterprise 2 stent (b)(6) was impeded in the y-connector and could not be further advanced.The physician retracted the stent and it became automatically released.The stent component was prematurely separated from the delivery wire.The physician replaced the stent to complete the procedure using the original 150cm x 5cm prowler select plus microcatheter (606s255x) microcatheter.There was no report of any negative patient impact.On 18-feb-2024, additional information was received.Per the information, the location of the targeted aneurysm was the middle cerebral artery.A continuous had been maintained through the microcatheter.There was no damage observed on the stent / stent delivery system.Nothing unusual was noted about the system prior to use.The replacement stent was another 4mm x 30mm enterprise 2 stent (b)(6) there was no procedure delay as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (6948539) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 30mm enterprise 2 stent was received contained in the decontamination pouch.Visual inspection was performed.It was observed that the stent was already detached from the unit and was not returned for evaluation.The delivery wire and the introducer were noted to be in good condition (i.E., no kinks, no bends, no elongation).The delivery wire underwent dimensional analysis.All measurements were within specifications, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The issue documented that the stent became impeded in the y-connector cannot be evaluated through a functional test since during the analysis, the stent was found to be no longer on the delivery wire.Based on this condition the issue regarding a stent being prematurely detached was confirmed.It is possible that the delivery wire was pulled sufficiently to disengage it from the stent in the attempt to retract the stent; however, with the evidence available, a clear relationship between this finding and the issue reported cannot be drawn at this time.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the enterprise device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6948539.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on (b)(6) 2024.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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: ENTERPRISE2 4MMX30MM
• 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: 18744463
• MDR Text Key: 336788635
• Report Number: 3008114965-2024-00194
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 6948539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 03/27/2024
• Supplement Dates FDA Received: 03/20/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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
• Treatment: PROWLER SELECT PLUS 150/5CM