MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402300

Device Problem Premature Activation (1484)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).Section e1.Initial reporter phone: (b)(6).Section h3 - 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.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 by the field, the physician opened the packaging of an enterprise2 4mmx23mm no tip intracranial stent (encr402300, 8219125) and removed the device from dispenser hoop.It was found that the stent was released automatically.The stent body was separated prematurely from the delivery wire.The device was not used in patient.Physician switched a new stent to complete the surgery.There was no patient injury as the device was not clinically used.Additional event information received on 16-apr-2024 indicated that there had not been any packaging issues.The inner pouch was securely sealed.The device was stored and prepped as per the instructions for use (ifu).

Manufacturer Narrative

Product complaint (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, the physician opened the packaging of an enterprise2 4mmx23mm no tip intracranial stent (encr402300, 8219125) and removed the device from dispenser hoop.It was found that the stent was released automatically.The stent body was separated prematurely from the delivery wire.The device was not used in patient.Physician switched a new stent to complete the surgery.There was no patient injury as the device was not clinically used.Additional event information received on 16-apr-2024 indicated that there had not been any packaging issues.The inner pouch was securely sealed.The device was stored and prepped as per the instructions for use (ifu).A non-sterile enterprise2 4mmx23mm no tip was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that the stent was detached from the delivery system and remained inside the proximal section of the introducer.The introducer and the delivery wire were found to be in good condition.The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The customer complaint regarding a premature deployment of the stent during the removal from the hoop was confirmed due to the detached condition of the stent; however, this condition suggests that the delivery wire was retracted sufficiently to cause the delivery wire to disengage the stent from the delivery system.Since the stent was found in the proximal section of the introducer, it is suggested that the delivery system was retracted with the use of excessive force, enough to release the stent inside of the introducer tube.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8219125.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.Therefore, no capa activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: ¿ carefully place the dispenser hoop into the sterile field.¿ remove the delivery wire from the clip on the dispenser hoop.Grasp the proximal end of the introducer and the delivery wire at the point where it exits the introducer.Hold wire and introducer together to prevent stent movement.Remove the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.¿ do not partially deploy the stent from the introducer.¿ confirm that the delivery wire does not move relative to the introducer during the removal of the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.¿ confirm the tip of the delivery wire is entirely within the introducer.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.

• Brand Name: ENTERPRISE2 4MMX23MM 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: 19120985
• MDR Text Key: 340344905
• Report Number: 3008114965-2024-00406
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 8219125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2023
• 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