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

Catalog Number ENC452212

Device Problem Activation Failure (3270)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(6).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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8129995.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 an angioplasty procedure, the complaint device, a 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212 / 8129995) was placed in the target position and the physician started to release it, but the distal markers were unable to open.The physician withdrew the stent and attempted to release it again, but the markers still failed to open.The physician retracted the stent and replaced it with a new stent to complete the procedure using the original concomitant microcatheter (unspecified brand).There was no negative patient impact reported.On 06-nov-2023, additional information was received.The information confirmed the procedure was an angioplasty procedure.The target vessel of the treatment was the basilar tip.Vessel factors were not contributing factors to the incomplete expansion.There were evidence of obstructed blood flow due to the reported issue.The temperature indicator label on the inner pouch had been checked and found to be within acceptable criteria.Per the information, there had been no resistance during advancement of the stent.The replacement stent was another 4.5mm x 22mm enterprise® vascular reconstruction device (enc452212).The information also confirmed there were no negative patient impact.There were no clinically significant delay in the procedure due to the reported event.

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 04-dec-2023.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 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.Dried saline residues were noted inside the introducer tube.No appearance of damages were noted; the stent is still attached to the delivery system.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, and residues of dried blood were noted along the stent body.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8129995.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 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.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 4.5X22MM 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: 18145710
• MDR Text Key: 328770527
• Report Number: 3008114965-2023-00791
• 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: 01/04/2024

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: 8129995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/04/2023; 01/04/2024
• Supplement Dates FDA Received: 12/05/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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