MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during the procedure, the 4mm x 23mm enterprise 2 stent (encr402312 / 8314213) was impeded in the proximal section of the concomitant microcatheter (unspecified brand) and could not advance further.The physician retracted the stent and found that the stent markers were fractured.A new stent was used to complete the procedure using the original microcatheter.There was no report of any negative patient impact.Two photos were included in the complaint.On 10-jan-2024, additional information was received.Per the information, the patient is an 81-year-old male with a history of left middle cerebral artery stenosis.The patient was admitted to the hospital due to an inability to speak and right limb weakness for 3 hours.He was diagnosed with left middle cerebral artery occlusion in the hospital emergency department.The information indicated that the target vessel of the procedure was the basilar artery.The concomitant microcatheter used was a prowler select plus (606s255x / 31135558).A continuous flush was maintained through the microcatheter.When the stent was removed, it was reportedly still on the delivery wire.The replacement stent was another 4mm x 23mm enterprise 2 stent (encr402312).There was no procedure delay due to the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section e.1: (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 product analysis lab team reviewed the photos included in the complaint.The review is documented below.[photo review]: two photos were included in the complaint file, in which it was noted that the stent was partially deployed outside of the introducer.The released portion shows the distal struts broken.No other damages could be discerned on the delivery wire or the stent.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8314213.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 being impeded in the microcatheter and then being fractured was confirmed during the photo inspection, the broken condition noted in the stent is suggested to be secondary to the resistance felt during the stent advancement.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.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 analysis lab received the complaint device on (b)(6) 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.

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 4mm x 23mm enterprise 2 stent was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was still attached to the delivery wire inside the introducer.No appearance of damage was observed.The stent system was advanced through a lab sample prowler select plus 150/5cm, and it reached the distal end without noticeable resistance.Once the stent came out from the microcatheter it was inspected under magnification, and the distal struts were found fractured, as seen in the photos included in the complaint.It is suggested that the introducer tip was not fully seated in the hub, and during the stent advancement, excessive force was inadvertently applied in an attempt to overcome the difficulties experienced which ultimately resulted in the struts being fractured.There may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.Based on this, the customer complaint was confirmed.However, 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 8314213.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: ¿ if resistance is met during manipulation, determine the cause of resistance before proceeding.¿ do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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 4MMX23MM
• 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: 18548271
• MDR Text Key: 333507804
• Report Number: 3008114965-2024-00017
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 8314213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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: PROWLER SELECT PLUS 150/5CM.
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian