MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC452212

Device Problem Premature Activation (1484)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the physician opened the device packaging and removed the complaint device, a 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 8028689) from the dispenser hoop, it was found that the stent component was automatically released.The stent component was prematurely separated from the delivery wire.The physician switched to a new stent to complete the procedure.There was no report of patient injury.On 09-nov-2023, additional information was received.The information indicated the target vessel of the procedure was the middle cerebral artery (mca).The response provided as related to whether the stent / stent delivery system was damaged was ¿yes, the stent was released automatically and the stent was separated from the delivery wire.¿ the replacement stent was another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212).The reported issue did not result in any clinically significant delay in the procedure.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section e.1: initial reporter facility name: (b)(6) 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 8028689.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 04-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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 investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4.5mm x 22mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was still attached to the delivery wire and inside the introducer.No appearance of damages were observed.The stent length was measured and confirmed to be within specifications.The reported issue documented in the complaint regarding a premature deployment of the stent during the removal from the hoop was not confirmed as the stent was found still attached to the delivery wire.There is no indication that the reported issues are a result of a defect inherently related to the enterprise device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028689.The history record indicates 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.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.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: EU 4.5X22MM 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: 18112603
• MDR Text Key: 328995408
• Report Number: 3008114965-2023-00784
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 8028689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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