MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

Device Problem Activation Failure (3270)

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

Event Date 01/04/2024

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.One image was received, and the review was made by an independent physician the results are shown below: ¿the description of the complaint is clear.There is one image supplied of a pcom aneurysm on the right side that is being coiled and a microcatheter distal to it.On this single image there is no unsheathing of the stent visible and therefore the image doesn¿t add extra information.Failure of a stent to open may have multiple causes such as clot build up at the distal end of the stent, entanglement of the stent struts, target vessel vasospasm or the presence of a local stenosis.In this case, a second stent was fully deployed, thus eliminating vessel related causes for failure of stent opening.If the failed device is returned it can be checked for the other factors, as the image provided does not permit further interpretation.¿ 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.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 the procedure, a eu ent4.5mmd 22mml wno dstl tp intracranial stent (enc452200, 7187279) was placed in target position and started to release, but the distal markers of the stent were converged which could not be opened.After several attempts, the stent markers still failed to open.The doctor retracted the stent and switched to a new one to complete the surgery.The microcatheter was not replaced.The procedure was prolonged about 10 minutes.Additional information received on 01-feb-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.No additional intervention was performed to attempt to expand the stent.The incomplete expansion did not result in stent migration or embolization of the stent.There was no blood flow restriction.The 10 minute prolongation of the procedure was not clinically significant.

Manufacturer Narrative

Product complaint # (b)(4).A non-sterile eu ent4.5mmd 22mml wno dstl tp intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the stent component was found detached from the delivery wire and stuck at the proximal end of the introducer.The proximal end of the introducer was warped.Microscopic inspection on the delivery wire revealed that the proximal end of the proximal coil was stretched, and the distal end of the proximal coil had several curved conditions.The stent component was removed from the introducer, and inspected under magnification, no abnormalities were found on it (i.E., no broken struts, no kinks).Both ends of the stent were noted to be completely expanded.The introducer component was confirmed to be within specifications for the outer diameter (od) and the distal inner diameter (id).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 issue reported regarding the distal markers of the stent being converged could not be confirmed since the stent was confirmed to be undamaged and completely expanded.The stent detachment, along with the warped condition of the introducer, and stretched condition of the delivery wire, were not originally reported, and no resistance to advance nor retrieve the stent was reported.These findings are not contributing factors to the stent's inability to open experienced during the procedure.With the limited information available, the root cause of the reported failure remains inconclusive; however, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.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 at this time.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.The introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.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 ENT4.5MMD 22MML WNO DSTL TP
• 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: 18659654
• MDR Text Key: 336079037
• Report Number: 3008114965-2024-00204
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452200
• Device Lot Number: 7187279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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)