MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Activation Failure (3270)

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

Event Date 02/29/2024

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.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 a endovascular embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8137618) was placed in target position and started to release, but the distal markers of the stent were converged could not be opened.After several attempts, the stent markers still failed to open.The doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 20 minutes.Additional event information received on 07-mar-2024 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There was no blood flow restriction.

Manufacturer Narrative

Product complaint (b)(4).Complaint conclusion: as reported by the field, during a endovascular embolization, an eu 4.5x22mm stent 12 mm dw tip intracranial stent (enc452212, 8137618) was placed in target position and started to release, but the distal markers of the stent were converged could not be opened.After several attempts, the stent markers still failed to open.The doctor retracted the stent and switched a new one to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 20 minutes.Additional event information received on 07-mar-2024 indicated that the temperature indicator label on the inner pouch was checked and found to be within acceptable criteria.There was no resistance during advancement of the device.The stent did not appear damaged.There were no vessel or aneurysm factors that may have contributed to the incomplete expansion.No additional intervention was performed to attempt to expand the stent.There was no blood flow restriction.A non-sterile eu 4.5x22mm stent 12 mm dw tip was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.All the components were received in good condition.Further inspection was performed under a microscope, the delivery wire was inspected along its entire length, and no damages were found.The stent was found still inside the introducer.Some residues of dried saline solution were found inside the introducer.The functional test was performed; a lab sample prowler select plus was flushed using a lab sample syringe.After that, the unit enterprise was introduced into the lab sample prowler select plus, and it advanced; no resistance/friction was felt when the stent passed through the hub area.The stent came out from the distal tip of the microcatheter.Once the stent was detached from the unit, it was inspected under a microscope, and it was observed to be in good condition, with no structural damage (i.E., no broken struts, no kinks); both of the distal ends were seen completely flared.The issue documented in the complaint regarding the stent distal markers of the stent converged was not confirmed since the stent was found fully expanded during the analysis.It is possible that the marker bands may have converged together but opposed to the vessel wall.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 issues reported in the complaint are 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 8137618.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 no device deficiency was found, 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: maintain adequate stent length (approximately 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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: EU 4.5X22MM STENT 12 MM DW 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: 18930657
• MDR Text Key: 339083713
• Report Number: 3008114965-2024-00314
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 8137618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2023
• 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