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

Catalog Number ENC452212

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref (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) medicine 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 8302857.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.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 stent-assisted coil embolization procedure, after balloon dilation, the physician began to deliver a 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 8302857).The stent was impeded in the introducer and could not be pushed into the microcatheter.The physician retracted the stent for inspection and observed that it had been prematurely detached, separated from the delivery wire.There was no report of any negative patient impact.

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.The stent was observed already detached from the delivery system and it is still remaining inside the proximal section of the introducer.The stent component was inspected under the microscope.Under magnification, no damages were observed on it.Further inspection revealed that the delivery wire was broken off just proximal to the retraction bump; the fragment of the delivery wire was within the stent inside the introducer.The inner diameter (id) and outer diameter (od) of the introducer were confirmed to be within specifications.The condition of the returned 4.5mm x 22mm enterprise® vascular reconstruction device precluded functional testing.However, the condition of the delivery wire suggest that it was pushed sufficiently enough to cause the delivery wire to bend and end up breaking.Since the stent was found in the proximal section of the introducer, it is suggested that the delivery system was retracted with the use of excessive force, enough to release the stent inside of the introducer tube.The issue reported in the complaint was confirmed, however, there is no indication that the issue reported in the complaint is a result of 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 8302857.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) contains the following recommendations: ¿ if resistance is met during manipulation, determine the cause of resistance before proceeding.¿ the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.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.

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 20-mar-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: 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 ; 303552-689
• MDR Report Key: 18881490
• MDR Text Key: 337404183
• Report Number: 3008114965-2024-00267
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 8302857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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: BALLOON CATHETER (UNSPECIFIED BRAND).; MICROCATHETER (UNSPECIFIED BRAND).; REBAR¿ 18 MICROCATHETER (MEDTRONIC).