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

Catalog Number ENC451412

Device Problem Material Separation (1562)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

As reported by the field, prior to the procedure, the physician removed an eu 4.5x14mm stent 12 mm dw tip intracranial stent from the dispenser hoop for inspection and observed the delivery wire was broken.There was no patient injury as the device was not clinically used.A new device was switched to complete the surgery.Additional information received indicated that the distal tip of the enterprise was not re-shaped prior to use.There was no excessive force applied to the device.The device was stored and prepped per the instructions for use (ifu).

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).Four pictures were attached to the complaint file; however, in two of them, only the outer box was shown.In the rest of the pictures, it was noted that the stent remain inside of the introducer tube.However, the distal portion of the delivery wire was noted to be broken in two.No other damages can be seen in the device.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 7632759.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The issue regarding a delivery wire being broken was confirmed based on the broken condition of the delivery wire.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.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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, prior to the procedure, the physician removed an eu 4.5x14mm stent 12 mm dw tip intracranial stent from the dispenser hoop for inspection and observed the delivery wire was broken.There was no patient injury as the device was not clinically used.A new device was switched to complete the surgery.Additional information received indicated that the distal tip of the enterprise was not re-shaped prior to use.There was no excessive force applied to the device.The device was stored and prepped per the instructions for use (ifu).Four pictures were attached to the complaint file; however, in two of them, only the outer box was shown.In the rest of the pictures, it was noted that the stent remain inside of the introducer tube.However, the distal portion of the delivery wire was noted to be broken in two.No other damages can be seen in the device.A non-sterile 4.5 mm x 14 mm enterprise® with 12 mm tip vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was found that only the delivery wire was returned for evaluation.The returned device was observed under magnification and a kinked condition can be observed in the delivery wire tip segment.Also, a separation of the delivery wire tip from the rest of the device is observed.The issue reported regarding the delivery wire component being broken was confirmed during the inspection; the kinked condition noted in the wire suggests that it is possible that excessive force was inadvertently applied, which ultimately led to the separation of the delivery wire.Clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the device.The introducer and the stent may have gotten lost during the post-procedural handling since, in the provided pictures these were shown.If additional information or components are received at a later time, this investigation will be reassessed accordingly.(b)(6) did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 7632759.The history records indicate this product was final inspection tested at (b)(6) 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) 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 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: 17825526
• MDR Text Key: 324366558
• Report Number: 3008114965-2023-00699
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• 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: 7632759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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