MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403000

Device Problem Failure to Advance (2524)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during a stent-assisted aneurysm embolization procedure, the 4mm x 30mm enterprise 2 stent (encr403000 / 8130003) was impeded in the proximal area of the headway® 21 microcatheter (microvention) and could not be further advanced.The physician removed the stent and the microcatheter from the patient and replaced the microcatheter with a 150cm x 5cm prowler select plus microcatheter (606s255x / lot# unknown) and made another attempt to deliver the stent, but the same issue was encountered.The physician retracted the stent and replaced it with a new stent to complete the procedure using the 150cm x 5cm prowler select plus microcatheter.The procedure was prolonged by approximately 10 minutes.There was no report of any negative patient impact.On (b)(6)2024, additional information was received.Per the information the patient is a 68-year-old female.The intended procedure was a carotid artery stent-assisted coil embolization.When the stent was removed from the patient, it was still on the delivery wire.There was an adequate continuous flush maintained through the microcatheter.The stent / stent delivery system did not appear damaged.The replacement stent was another 4mm x 30mm enterprise 2 stent (encr403000).The information confirmed there was no negative patient impact and the physician did not consider the 10 minute procedure to be clinically significant.

Manufacturer Narrative

Manufacturer¿s ref.No pc-(b)(4).Information regarding patient identifier, date of birth, 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 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 8130003.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00293 and 3008114965-2024-00294.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.(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 4mm x 30mm enterprise 2 stent was received contained in the decontamination pouch.Visual inspection was performed.The stent component was observed still attached to the delivery wire and inside the introducer.No appearance of damages were observed.Microscopic inspection was performed, and no damages were observed on the stent, nor on the introducer or delivery wire components.The stent was advanced through a lab sample prowler select plus 150/5cm, and it reached the distal end without noticeable resistance.The delivery wire and introducer components were neither damaged during nor after the functional testing.The issue regarding a stent component being impeded in the microcatheter was not confirmed, since 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 issue reported in the complaint results from a defect inherently related to the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8130003.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 instructions for use (ifu) does 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.¿ the cerenovus enterprise vascular reconstruction device and delivery system is designed for use under fluoroscopy with the prowler® select¿ plus infusion catheter, (a 0.021-inch inner diameter, 5 cm distal length infusion catheter manufactured by cerenovus).Caution: compatibility with other infusion catheters has not been established.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00293 and 3008114965-2024-00294.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 4MMX30MM 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: 18975895
• MDR Text Key: 339321970
• Report Number: 3008114965-2024-00293
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403000
• Device Lot Number: 8130003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2023
• 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: HEADWAY® 21 MICROCATHETER (MICROVENTION).; PROWLER SELECT PLUS 150/5CM.
• Patient Age: 68 YR
• Patient Sex: Female