MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X14MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC451412

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 03/25/2024

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 of the photos that accompanied the complaint file shows the detached stent on a gauze.The stent was noted completely flared and no visible damages were noted.The rest of the device is not observed in the photo and cannot be evaluated.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 8302879.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.Therefore, no capa activity is required.The issue regarding a stent being released automatically was confirmed based on the detached condition of the stent, however, the issue regarding a stent being impeded 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

Event Description

As reported by the field, during an endovascular embolization, an eu 4.5x14mm stent 12 mm dw tip intracranial stent (enc451412, 8302879) became impeded in distal end of a non j&j microcatheter (mc) and was released automatically, which could not pass through the microcatheter.The physician removed the microcatheter and stent from the patient and observed that the stent body was found to be separated prematurely from the delivery wire.A new stent was switched with the same microcatheter to complete the surgery.Additional event information received on 08-apr-2024 indicated that there was no evidence of physical material within the device.Other devices were successfully used with the concomitant device prior to the encountered resistance.There were no procedural delays due to the event.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an eu 4.5x14mm stent 12 mm dw tip intracranial stent (enc451412, (b)(6)) became impeded in distal end of a non j&j microcatheter (mc) and was released automatically, which could not pass through the microcatheter.The physician removed the microcatheter and stent from the patient and observed that the stent body was found to be separated prematurely from the delivery wire.A new stent was switched with the same microcatheter to complete the surgery.Additional event information received on (b)(6) 2024 indicated that there was no evidence of physical material within the device.Other devices were successfully used with the concomitant device prior to the encountered resistance.There were no procedural delays due to the event.One of the photos that accompanied the complaint file shows the detached stent on a gauze.The stent was noted completely flared and no visible damages were noted.The rest of the device is not observed in the photo and cannot be evaluated.A non-sterile eu 4.5x14mm stent 12 mm dw tip was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and as seen in the provided picture the stent was already detached from the unit.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The delivery wire was 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 customer complaint regarding a stent being released automatically was confirmed since the stent was noted as already separated from the delivery system; based on this condition, the issue regarding a stent that could not pass 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.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8302879.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.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.

• Brand Name: EU 4.5X14MM 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19062051
• MDR Text Key: 339682931
• Report Number: 3008114965-2024-00382
• 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: 05/06/2024

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: ENC451412
• Device Lot Number: 8302879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND).