MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4), information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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 Description

As reported by the field, during an endovascular embolization, an enterprise2 4mmx23mm intracranial stent (encr402312, 8582199) became impeded in y connector and could not advance any more.The physician retracted the stent and it was released automatically.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The microcatheter (other brand) was not replaced.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an enterprise2 4mmx23mm intracranial stent (encr402312, 8582199) became impeded in y connector and could not advance any more.The physician retracted the stent and it was released automatically.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The microcatheter (other brand) was not replaced.There was no patient injury reported.No additional information is available.A non-sterile enterprise2 4mmx23mm 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 and this was not returned for evaluation.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).Residues of dried saline solution were noted on the delivery wire.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 stent being prematurely detached was confirmed since the stent was noted as already separated from the delivery system; based on this condition, the issue regarding a stent being impeded in the y connector cannot be evaluated through functional testing.The stent must be inside the introducer tube to perform the functional analysis.Additionally, none of the returned components present damages that suggest that they were forcibly advanced.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support 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 8582199.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.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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 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
• 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: 18986932
• MDR Text Key: 338765924
• Report Number: 3008114965-2024-00346
• 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,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 8582199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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
• Treatment: MICROCATHETER (UNSPECIFIED BRAND)