MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENF403900
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.One picture was attached to the complaint file in which it was noted that the stent is already detached from the unit; this was noted completely flared and without noticeable damage.No damages were noted in the distal portion of the delivery wire and the introducer.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of lot 7507671.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.The issue regarding a stent prematurely detached was confirmed since the stent was noted to be already separated from the unit.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 or Problem Description
As reported by the field, an enterprise2 4mmx39mm no tip intracranial stent (enf403900, 7507671) was pre-deployed, when it was opened.There was no patient injury as the device was not clinically used.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, an enterprise2 4mmx39mm no tip intracranial stent (enf403900, 7507671) was pre-deployed, when it was opened.There was no patient injury as the device was not clinically used.No additional information was provide.One picture was attached to the complaint file in which it was noted that the stent is already detached from the unit; this was noted completely flared and without noticeable damage.The delivery wire and the introducer were not shown in the picture and cannot be evaluated.A non-sterile 4mm x 39mm enterprise® 2 vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit.The delivery wire and the introducer were not returned for evaluation.These conditions are consistent with the conditions seen in the provided picture.Further inspection was performed under a microscope; the stent was observed to be in good condition, with no structural damage (i.E., no broken struts, no kinks).The customer complaint regarding a premature deployment of the stent was confirmed due to the detached condition of the stent; however, the exact contributing factors to this issue could not be identified.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The delivery wire and the introducer components might have gotten lost sometime during the post-operative handling or decontamination of the device.If additional information or components are received at a later time, this investigation will be reassessed accordingly.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of lot 7507671.The historical record indicates 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 the wire and introducer together to prevent stent movement.Remove the codman 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 codman 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 4MMX39MM NO TIP
• Common Device Name: 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: 17381293
• Report Number: 3008114965-2023-00520
• Device Sequence Number: 14934781
• Product Code: NJE
• UDI-Device Identifier: 10886704075400
• UDI-Public: 10886704075400
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2025
• Device Catalogue Number: ENF403900
• Device Lot Number: 7507671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown