MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452200

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

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

As reported by the field, during an endovascular embolization of the middle cerebral artery, an eu ent4.5mmd 22mml wno dstl tp intracranial stent ( enc452200, 8269486) became impeded in the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not pass through the microcatheter (mc).The physician removed the microcatheter and stent from the patient.The stent was found to be released in the microcatheter and the stent body was separated prematurely from the delivery wire.The stent body was remained in the microcatheter.The doctor switched to new devices to complete the surgery.There was no patient injury reported.Additional event information was received on 11-jan-2024 indicating that the physician did not torque the device.There was no evidence of physical material within the device.The stent was impeded in distal end of the microcatheter.There were no procedural delays.

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.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2024-00081.

Manufacturer Narrative

Product complaint(b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization of the middle cerebral artery, an eu ent4.5mmd 22mml wno dstl tp intracranial stent (enc452200, 8269486) became impeded in the prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not pass through the microcatheter (mc).The physician removed the microcatheter and stent from the patient.The stent was found to be released in the microcatheter and the stent body was separated prematurely from the delivery wire.The stent body was remained in the microcatheter.The doctor switched to new devices to complete the surgery.There was no patient injury reported.Additional event information was received on 11-jan-2024 indicating that the physician did not torque the device.There was no evidence of physical material within the device.The stent was impeded in distal end of the microcatheter.There were no procedural delays.A non-sterile eu ent4.5mmd 22mml wno dstl tp intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed and it was noted that the stent component was found detached inside the luer hub of the concomitant microcatheter.The introducer and the delivery wire were not returned for evaluation.The stent was removed from the luer hub of the microcatheter and it was inspected under the magnification, no abnormalities were found on it (i.E.No broken struts, no kinks).Both of the stent ends were noted to be completely expanded.The delivery wire was also inspected and it was found in good normal condition.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8269486.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported regarding the stent being impeded in the microcatheter could not be evaluated due to the detached condition of the stent.This component must still be attached to the delivery wire and inside the introducer to perform a functional analysis; however, the issue reported regarding the stent being prematurely released in the microcatheter was confirmed since the stent was found detached inside the microcatheter's hub.This condition suggests that the enterprise introducer was not fully seated in the hub of the microcatheter, causing the stent to expand in the microcatheter's hub, resulting in the stent component being unable to advance further, where push/pull force was applied sufficiently to disengage the stent from the delivery wire.However, with the amount of information available and the lack of returned components this only remains speculative.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 multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: do not partially deploy the stent from the introducer.Confirm the tip of the delivery wire is entirely within the introducer.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 ENT4.5MMD 22MML WNO DSTL TP
• 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: 18526975
• MDR Text Key: 333513862
• Report Number: 3008114965-2024-00080
• 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: 02/08/2024

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: ENC452200
• Device Lot Number: 8269486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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: PROWLER SELECT PLUS 150/5CM
• Patient Age: 58 YR
• Patient Sex: Male