MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problem Failure to Advance (2524)

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

As reported by the field, during an endovascular embolization, an enterprise2 4mmx23mm intracranial stent ( encr402312, 8560406) was in place and started to release.The stent was found to be impeded in prowler select plus 150/5cm (606s255x, 31154822) microcatheter tip and could not be released.The physician removed the microcatheter (mc) and stent from the patient, then switched to new devices to complete the surgery.The surgery was prolonged about 10 minutes.

Manufacturer Narrative

Product complaint # (b)(4).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 photo accompanied the complaint file shows the tip of the delivery system passing the involved microcatheter tip and no damages were observed on it.The stent was noted to be no longer attached to the delivery system.The rest of the device is observed to remain inside the involved microcatheter and cannot be evaluated.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 8560406.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The issue regarding a stent being impeded in the microcatheter cannot be evaluated through images, a functional test needs to be performed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00388 and 3008114965-2024-00389.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an enterprise2 4mmx23mm intracranial stent (encr402312, (b)(6)) was in place and started to release.The stent was found to be impeded in prowler select plus 150/5cm (606s255x, (b)(6)) microcatheter tip and could not be released.The physician removed the microcatheter (mc) and stent from the patient, then switched to new devices to complete the surgery.The surgery was prolonged about 10 minutes.Additional event information received on 12-apr-2024 indicated that they were able to torque the device.Other non j&j devices were successfully used with the concomitant device prior to the encountered resistance.There was no excessive force used with the device.The mc did not kink or bend.The 10 minute procedural delay was not clinically significant.One photo accompanied the complaint file shows the tip of the delivery system passing the involved microcatheter tip and no damages were observed on it.The stent was noted to be no longer attached to the delivery system.The rest of the device is observed to remain inside the involved microcatheter and cannot be evaluated.A non-sterile 4.5mm x 23mm enterprise 2 was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was observed that the delivery wire remained inside the involved microcatheter.The introducer component was not returned for evaluation.The involved microcatheter was flushed in order to try to remove the involved enterprise stent; however, strong resistance was felt.Then, the microcatheter was dissected at different points; dried clots, and residues of dried blood were found in the inner lumen.The delivery system was not able to be removed.As seen in the provided picture the stent was noted be already detached from the delivery system and there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, and both ends can be noted as completely flared.The issue reported in the complaint that the enterprise device became impeded in the microcatheter was confirmed based on the condition of the returned device; however, with the information available and the evidence obtained from the returned devices, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.It is suggested that an adequate continuous flush had not been maintained through the microcatheter due to the amount of residue found in the microcatheter, without an adequate flush, issues such as resistance between the delivery wire and the microcatheter can arise.Other circumstances or issues may occur while using the device that could not be replicated during the analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8560406.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 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 product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ 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.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).Section b5: additional event information received on 12-apr-2024 indicated that they were able to torque the device.Other non j&j devices were successfully used with the concomitant device prior to the encountered resistance.There was no excessive force used with the device.The mc did not kink or bend.The 10-minute procedural delay was not clinically significant.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX23MM
• 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: 19079597
• MDR Text Key: 340691967
• Report Number: 3008114965-2024-00388
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 8560406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 04/24/2024
• Supplement Dates FDA Received: 04/15/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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
• Treatment: NON J&J GUIDE WIRE.; PROWLER SELECT PLUS 150/5CM.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian