MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problems Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter phone: (b)(6).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.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 a stent assist coil embolization, a 4mm x 30mm enterprise2 intracranial neurovascular stent (encr403012, 6812679) was advanced within the unspecified microcatheter (mc) and the physician felt some resistance.After stent was placed in target position, the doctor tried to release the stent, but the stent was unable to open.After several attempts, the stent still could not be opened.Then, a new stent was switched to complete the surgery smoothly (the microcatheter was not replaced).There was no patient injury reported.Additional information received indicated that the system used with the recommended microcatheter.There was no damage to the device or concomitant device.The device and microcatheter were carefully advanced as a unit until the microcatheter tip was positioned just proximal to the aneurysm neck and at the level of the vessel bifurcation.An adequate continuous flush was maintained through the microcatheter.The delivery wire and microcatheter were gently pulled back until the excess slack was removed and the tip of the microcatheter began to move.The device had been deployed twice.During device deployment, the delivery wire was held stationary while withdrawing the microcatheter.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, a 4mm x 30mm enterprise2 intracranial neurovascular stent (encr403012, 6812679) was advanced within the unspecified microcatheter (mc) and the physician felt some resistance.After stent was placed in target position, the doctor tried to release the stent, but the stent was unable to open.After several attempts, the stent still could not be opened.Then, a new stent was switched to complete the surgery smoothly (the microcatheter was not replaced).There was no patient injury reported.Additional information received indicated that the system used with the recommended microcatheter.There was no damage to the device or concomitant device.The device and microcatheter were carefully advanced as a unit until the microcatheter tip was positioned just proximal to the aneurysm neck and at the level of the vessel bifurcation.An adequate continuous flush was maintained through the microcatheter.The delivery wire and microcatheter were gently pulled back until the excess slack was removed and the tip of the microcatheter began to move.The device had been deployed twice.During device deployment, the delivery wire was held stationary while withdrawing the microcatheter.A non-sterile 4mm x 30mm enterprise2 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.The delivery wire and the introducer were returned for evaluation; both were found to be in good condition (i.E., no kinks, no fractures, or separations).The stent component was inspected under a microscope and no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the distal ends were noted to be completely expanded.The customer complaint regarding a stent impeded in the microcatheter could not be evaluated through functional testing since the stent was already deployed.The residues of dry blood found inside the introducer suggest that continuous flush had not been done without an adequate flush issue such as resistance between the delivery system and the microcatheter can arise.However, this cannot be conclusively determined.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.The customer 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 apposed to the vessel wall.The stent detachment was not originally documented in the complaint and the exact time when this condition occurred cannot be determined based on the information available, however, this finding is not a contributing factor to the stent's inability to open experienced during the procedure.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.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of lot 6812679.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 product failure could be caused by multiple factors.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.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.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.

Manufacturer Narrative

Product complaint #
=
> (b)(4).The medical imaging was reviewed by cerenovus sr.Medical affairs director, and the assessment reads as follows: ¿from the description, we learn that the first enterprise stent did not open.The reason for this is not clear from the description, nor from the provided 3d image which only shows a pre-implantation still shot of the aneurysm.Non-opening of stents can have multiple reasons such as positioning of the tip in a side branch, local vasospasm, clotting in the catheter if the flush is interrupted or mechanical failure.Further analysis of the device may help in finding the culprit¿.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX30MM
• 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: 16004672
• MDR Text Key: 305944254
• Report Number: 3008114965-2022-00862
• 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,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 6812679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• 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
• Treatment: UNSPECIFIED MICROCATHETER
• Patient Age: 55 YR
• Patient Sex: Female