MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF402300

Device Problems Component Missing (2306); Failure to Advance (2524)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section h.3: 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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6322171.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the tech removed the 4.0mm dia x 23mm enterprise®2 stent system (enf402300 / 6322171) from the hoop and handed it to the physician.The physician inserted the introducer into the microcatheter hub and the tech attempted to advance the system.While advancing the enterprise stent (under fluoro), the tech stated that it was hard to push through the microcatheter.The enterprise stent system never advanced through to the distal end of the microcatheter and could not be seen under fluoroscopy.The enterprise stent system was removed from the microcatheter and re-sheathed with the introducer sheath.The physician stated that there was no stent present on the enterprise system.The microcatheter was removed from the patient.The enterprise stent system and microcatheter was set aside on the back table.The procedure was completed with a competitor stent.There was no procedure delay due to the reported issue.The procedure was successfully completed without any negative patient impact.On 11-dec-2023, additional information was received.The information indicated that the procedure was on (b)(6) 2023.It was a stent-assisted coil embolization procedure with the target located on the right posterior cerebral artery (pca) to the basilar artery.The microcatheter used was a prowler select plus (catalog / lot# unknown).A continuous flush had been maintained through the microcatheter.The same microcatheter was not used with the competitor stent to complete the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 10-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 17-jan-2024.[additional information]: on 17-jan-2024, additional information was received via phone with the cerenovus sales representative.Per the information, ¿the stent system was hard to advance through the microcatheter, however physician continued to advance, but never saw the stent come out.The physician removed the system because he wanted to re-sheath it and at that time noticed that there was no stent present.The physician replaced the whole system, including microcatheter, since there was difficulty in advancing the stent, he did not want to continue with that microcatheter.There were no tortuous areas within the patient that could have caused the difficulty in advancing.Kim asked the technician prepping the device if it was possible that the stent detached during prep and the tech was adamant it did not detach.Physician has used enterprise several times before.¿.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.0mm dia x 23mm enterprise®2 stent system and the concomitant 150cm x 5cm prowler select plus microcatheter were received contained in the decontamination pouch.The delivery system was inside the introducer tube.The dispenser hoop was not returned for evaluation.Visual inspection was performed on the returned devices.No appearance of damage was observed.Under magnification, it was confirmed that the stent component was not attached to the delivery wire.Residues of saline solution were adhered to the proximal marker of the delivery wire.The 150cm x 5cm prowler select plus microcatheter was inspected, and it was confirmed that the stent component was not inside the microcatheter.The delivery wire and introducer components were 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 device history records (dhr) related to the manufacturing, inspection, and packaging of lot 6322171 indicate this product passed final inspection and was determined to be acceptable.Please note, final inspection requires verification of the stent.As part of the manufacturing process, there is a 100% in-process inspection that requires verification of the marker position and marker band alignment on the stent.The inspection also requires visual verification of the strut integrity of the stent and verification that the stent can move in the introducer.There is also a 100% inspection performed by quality after manufacturing.The 100% quality inspection consists of verification of marker band position on the stent and visual inspection for strut integrity of the stent.A review of the dhr of the impacted device verifies this inspection was performed for the affected lot.Based on the evidence obtained from the returned device, it was determined that the stent component was not attached to the delivery wire.However, since this device had been manipulated outside of their original packaging, the issue reported cannot be traced to the assembly of the device.It is unlikely that the stent component was originally missing from the enterprise system based on the dhr and review of the process controls in place.It is possible that pre-procedural factors may have contributed to the failure mode reported.The reported issue documented in the complaint regarding the stent being difficult to push through the microcatheter 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.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: carefully place the dispenser hoop into the sterile field.Remove the delivery wire from the clip on the dispenser hoop.Grasp the proximal end of the introducer and the delivery wire at the point where it exits the introducer.Hold wire and introducer together to prevent stent movement.Remove the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during the removal of the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Confirm the tip of the delivery wire is entirely within the introducer.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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: ENTERPRISE2 4MMX23MM NO 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 ; 303552-689
• MDR Report Key: 18410695
• MDR Text Key: 331520505
• Report Number: 3008114965-2023-00931
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075363
• UDI-Public: 10886704075363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: ENF402300
• Device Lot Number: 6322171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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: MICROCATHETER