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 02/04/2024

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 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.The photo included in the complaint was reviewed by the product analysis team.The review is documented below.[photo review]: the photo included in the complaint shows the stent released in the hub of the concomitant microcatheter.No appearance of damage was noted.The rest of the device is not shown in the photo and no further damages could be noted.(b)(6) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470644.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 component being prematurely detached from the delivery wire in the microcatheter hub was confirmed during the photo inspection, the stent was noted detached in the microcatheter's hub; however, the issue regarding resistance while delivering cannot be evaluated based on pictures, a functional analysis needs to be performed.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.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, when the 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 8470644) was just delivered to the concomitant microcatheter (unspecified brand), the stent encountered resistance.The physician retracted the stent; the stent component became prematurely detached from the delivery wire in the microcatheter hub.The physician removed the stent and replaced it with another stent to complete the procedure using the original microcatheter.There was no report of any negative patient impact.A photo was included in the complaint.The cerenovus sales representative provided the additional information via phone on (b)(6) 2024.Per the information, the location of the targeted aneurysm was the middle cerebral artery (mca).The concomitant microcatheter used was a cerenovus microcatheter, catalog and lot number unknown.A continuous flush had been maintained through the microcatheter.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).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 observed that the stent component was returned detached and inside the hub of the microcatheter.The delivery wire and introducer were not returned for evaluation.The stent component was attempted to be removed from the microcatheter's hub without success.The hub was inspected under x-ray imaging, and no appearance of damages was noted on the stent component.The issue reported regarding the stent encountering resistance while advancing the microcatheter could not be evaluated due to the detached condition of the stent since the stent must be still attached to the delivery wire and inside the introducer to perform the functional analysis.The issue reported regarding the stent becoming prematurely released in the microcatheter was confirmed since the stent was found detached inside the microcatheter's luer hub.This condition suggests that the enterprise introducer was not fully seated in the hub of the microcatheter, causing the stent to expand in the microcatheter's hub.However, with the amount of information available this only remains speculative.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470644.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: do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance to a new one.If resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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: 18773408
• MDR Text Key: 336638167
• Report Number: 3008114965-2024-00200
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8470644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 03/27/2024
• Supplement Dates FDA Received: 03/20/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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: MICROCATHETER