MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF401600

Device Problem Premature Activation (1484)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 can be seen the stent outside from the introducer, and already detached from the unit.The stent was noted to be not fully expanded however no damages can be seen on it.The rest of the device can be noted outside the hoop dispenser, and no damages were noted.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.The customer complaint was confirmed based on the detached condition noted in the stent.This investigation was performed based only on the photos provided.If the product is received after this investigation, we will perform an assessment according to the conditions of the device returned.A device history record (dhr) was performed, and no non-conformances were identified.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during the use of an enterprise2 4mmx16mm no tip intracranial neurovascular stent (enf401600, 6812675), the stent pre-deployed out of the dispenser.No patient injury was reported.

Manufacturer Narrative

Product complaint # (b)(6).Complaint conclusion: as reported by the field, during the use of an enterprise2 4mmx16mm no tip intracranial neurovascular stent (enf401600, 6812675), the stent pre-deployed out of the dispenser.No patient injury was reported.No additional information is available.No additional information was received.One picture was attached to the complaint file in which can be seen the stent outside from the introducer, and already detached from the unit.The stent was noted to be not fully expanded however no damages can be seen on it.The rest of the device can be noted outside the hoop dispenser, and no damages were noted.A non-sterile delivery wire of an enterprise2 4mmx16mm no tip was returned contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that only the delivery wire and introducer were returned.These components were found in good conditions (i.E., no kinks, no fractures, or separations).It should be noted that the stent component was not received with the rest of the device.Due to this, no further evaluation can be conducted.The stent could have been lost during the post-operative process since, in the provided pictures, the stent was shown as already detached; however, this remains only speculative.The customer complaint regarding a premature deployment of the stent during the removal from the hoop was confirmed based on the detached condition of the stent; however, the exact contributing factors to this issue could not be identified.There is no indication that the issue reported in the complaint results from 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 6812675.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.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 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 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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15796969
• MDR Text Key: 307326355
• Report Number: 3008114965-2022-00752
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: 10886704075349
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

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 Model Number: ENF401600
• Device Catalogue Number: ENF401600
• Device Lot Number: 6812675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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