MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF401600

Device Problem Premature Activation (1484)

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

Event Date 01/08/2024

Event Type  malfunction  

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 name, phone and email address of the initial reporter are not available / reported.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.The product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: the photo included in the complaint shows a detached stent.This was noted contained inside the original pouch and although it was noted to be compressed, no structural damage was observed.The rest of the delivery system was not shown in the photo.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7091644.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.The issue regarding a stent being prematurely released was confirmed based on the detachment condition of the stent.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.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.

Event Description

The healthcare professional reported that during a vascular stent placement procedure, the 4.0mm dia x 16mm with no tip enterprise®2 stent (enf401600 / 7091644) pre-deployed out of the dispenser.There was no report of any negative patient impact.A photo of the stent was included in the complaint.

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 4.0mm dia x 16mm with no tip enterprise®2 stent was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was already detached from the unit.The delivery wire and the introducer were not returned for evaluation.The stent component underwent microscopic inspection.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks).Both ends were noted as completely flared.The reported issue documented in the complaint regarding a premature deployment of the stent during the removal from the hoop was confirmed due to the detached condition of the stent; however, with the amount of information available and the lack of returned components, no further investigation can be conducted.It is possible that 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 enterprise device.The delivery wire and introducer components might have gotten lost sometime during the post-operative handling of the device.If additional information or components are received at a later time, this investigation will be reassessed accordingly.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7091644.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.Updated sections: b.4, 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 that the product analysis lab received the complaint device on (b)(6) 2024.A supplemental 3500a report will be submitted once the product investigation has been completed.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: ENTERPRISE2 4MMX16MM NO 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 ; 303552-689
• MDR Report Key: 18592169
• MDR Text Key: 334731288
• Report Number: 3008114965-2024-00024
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075349
• UDI-Public: 10886704075349
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENF401600
• Device Lot Number: 7091644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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