MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problems Failure to Advance (2524); Activation Failure (3270)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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 picture was attached to the complaint file in which the distal section of the enterprise was shown, and it was noted that the stent is still attached to the delivery wire.Some black residues were seen inside the introducer; these were suspected to be dried blood, which could explain why the stent could not be advanced through the introducer the second time.No other abnormalities were seen in the provided picture.The device history record (dhr) for lot number 7161632 was performed, and it indicated this product was final inspection tested and was determined to be acceptable.The customer complaint was not able to be evaluated since a functional analysis needs to be performed.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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

It was reported that during the procedure, the physician encountered some resistance when the eu 4.5x37mm stent 12 mm dw tip (enc453712/7161632) stent passed through the microcatheter tip, and the distal end of the stent could not be opened.The stent was removed from the patient¿s body.The doctor tried to deliver the stent again, but it was impeded in the introducer sheath and could not be pushed out.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: it was reported that during the procedure, the physician encountered some resistance when the eu 4.5x37mm stent 12 mm dw tip (enc453712/7161632) stent passed through the microcatheter tip, and the distal end of the stent could not be opened.The stent was removed from the patient¿s body.The doctor tried to deliver the stent again, but it was impeded in the introducer sheath and could not be pushed out.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.No additional information is available.One picture was attached to the complaint file in which the distal section of the enterprise was shown, and it was noted that the stent is still attached to the delivery wire.Some black residues were seen inside the introducer; these were suspected to be dried blood, which could explain why the stent could not be advanced through the introducer the second time.No other abnormalities were seen in the provided picture.A non-sterile eu 4.5x37mm 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 black residues seen in the provided picture were not found in the device.The introducer component was confirmed to be within specifications for the outer diameter (od) and the distal inner diameter (id).The stent was pushed out from the introducer and it came out from the distal tip without resistance.Then, 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.As the functional test was performed without issues, the impeded condition encountered during the procedure could not be confirmed.However, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The issue documented in the complaint regarding the stent not being able to open 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 7161632.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: ¿ the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.¿ maintain adequate stent length (approximately 5mm) on each side of the aneurysm neck to ensure appropriate neck coverage.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: EU 4.5X37MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16495679
• MDR Text Key: 310813233
• Report Number: 3008114965-2023-00153
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: ENC453712
• Device Lot Number: 7161632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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: UNSPECIFIED MICROCATHETER.