MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problem Activation Failure (3270)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the complaint device, a 4.5mm x 37mm enterprise® vascular reconstruction device (enc453712 / 7632765) was placed in the target site and an attempt to release the stent was made.The distal stent markers did not fully open or expand as intended.The physician retracted the stent and switched to a new stent to complete the procedure using the original concomitant microcatheter (unspecified brand).The procedure was prolonged by approximately 15 minutes.There was no negative patient impact reported.

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: (b)(6) hospital.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 7632765.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 was received in the product analysis lab on 13-dec-2023.The returned product is pending evaluation.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-dec-2023.[additional information]: on 05-dec-2023, additional information was received.The information indicated that the target aneurysm was unruptured.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.There was no evidence of obstructed blood flow due to the reported event.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.The microcatheter used was a cerenovus microcatheter; catalog and lot number was not obtainable.There had been no resistance during the advancement of the stent.The information confirmed that there was no negative patient impact.The 15-minute procedure extension was not considered clinically significant.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 37mm enterprise® vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.A functional test was performed in which the enterprise system was secured into a lab sample microcatheter through a lab sample syringe and rotating hemostasis valve (rhv).The system was flushed, and the enterprise system was advanced through the microcatheter without noticeable resistance.The stent was deployed and inspected under magnification.No abnormalities were found on it (i.E., no broken struts, no kinks).Both stent ends were noted to be completely expanded.Some residues of dried saline solution were noted.The issue reported regarding the distal markers of the stent being unable to open was not confirmed since the stent fully expanded during the analysis.It is possible that the marker bands may have converged together but apposed to the vessel wall.Although no product defect was identified, there may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.There is no indication that the issues reported in the complaint 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 7632765.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 product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.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 4.5X37MM 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 ; 303552-689
• MDR Report Key: 18262453
• MDR Text Key: 329701889
• Report Number: 3008114965-2023-00856
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC453712
• Device Lot Number: 7632765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• 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
• Treatment: MICROCATHETER (UNSPECIFIED BRAND)