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

Catalog Number ENCR402312

Device Problem Failure to Advance (2524)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier and date of birth 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 product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: one photo was included in the complaint.The delivery wire of the enterprise system appeared undamaged and is observed inside the prowler select plus microcatheter.The stent component is presumably stuck inside the microcatheter and cannot be observed.The issue reported that the stent could not pass through the microcatheter cannot be evaluated based on the photo; the photo does not provide evidence that there are damages on the enterprise system that may have contributed to the issue encountered during the procedure.Further inspection and testing will be conducted once the complaint devices are returned to the laboratory.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028668.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00913 and 3008114965-2023-00914.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.

Event Description

The healthcare professional reported that during an angioplasty procedure, the devices were flushed and inspected.The 150cm x 5cm prowler select plus microcatheter (606s255x / 31024383) was placed in the target site and the 4mm x 23mm enterprise 2 stent (encr402312 / 8028668) was delivered to the microcatheter.The stent was impeded in the distal end of the microcatheter and could not pass through the microcatheter.The physician tried to withdraw the stent, but it was stuck in the microcatheter and could not be retracted.The physician removed both devices from the patient¿s anatomy and switched to new devices to complete the procedure.There was no report of any negative patient impact.A photo of the devices was included in the complaint.Additional information was received on 07-dec-2023.Per the information, the procedure was a middle cerebral artery (mca) angioplasty in a 69-year-old female patient with no medical history.When the stent was removed from the patient, it was still on the delivery wire.There was no damage observed on the stent / stent delivery system.A continuous flush had been maintained through the microcatheter.There were no visible kinks nor other damages observed on the microcatheter.Nothing unusual was noted about the system prior to use.The replacement stent was another 4mm x 23mm enterprise 2 stent (encr402312).The replacement microcatheter was another 150cm x 5cm prowler select plus microcatheter (606s255x).The information confirmed there was no negative patient impact.There was no clinically significant delay in the procedure as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding 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 observed that the delivery wire remained inside the concomitant microcatheter.The introducer component was not returned for evaluation.The concomitant microcatheter was flushed in attempt to remove the enterprise stent; however, strong resistance was felt.The microcatheter was dissected at different points; dried clots, and residues of dried blood were found in the inner lumen.The delivery system could not be removed.The issue reported in the complaint that the enterprise device became impeded in the microcatheter was confirmed based on the condition of the returned device; however, with the information available and the evidence obtained from the returned devices, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The complaint detailed that a continuous flush had been maintained through the microcatheter; however, the amount of residue found in the microcatheter suggests that the flush may have not been adequate, without an adequate flush, issues such as resistance between the delivery wire and the microcatheter can arise.Other circumstances or issues may occur while using the device that could not be replicated during the analysis.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028668.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of 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) 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00913 and 3008114965-2023-00914.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 was received in the product analysis lab on 02-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00913 and 3008114965-2023-00914.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: 18351709
• MDR Text Key: 331074577
• Report Number: 3008114965-2023-00913
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: 8028668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian