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

Catalog Number ENCR402312

Device Problems Retraction Problem (1536); Malposition of Device (2616)

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

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported that a patient underwent a vascular stent placement procedure using a 4mm x 23mm enterprise 2 (encr402312/6441633) vascular reconstruction device (vrd) and that during the procedure the stent was not released into the lesion site.Per the event description, during the procedure, the stent arrived at the target position, but it was unintentionally released into the distal end of the vessel, and it did not cover the lesion site.The physician then released a new stent into the target position and completed the surgery.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, d9, g3, g6, h2, h3, h6, h10 and concomitant product.Section b5: additional information was received indicating that the target vessel being treated was reported to be the right middle cerebral artery.Vessel characteristic was claimed to be normal.The complaint device was prepped and used as per the ifu.There was no obvious resistance between the microcatheter and the stent.The microcatheter used was a 150cm x 5cm prowler select plus (606s255x).The information indicated that the concomitant devices functioned as expected.The stent was unexpectedly released in the vessel and could not be withdrawn.There was no delay to the procedure.Section h6: medical device problem code: retraction problem (a0510).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported that a patient underwent a vascular stent placement procedure using a 4mm x 23mm enterprise2 (encr402312/6441633) vascular reconstruction device (vrd) and that during the procedure the stent was not released into the lesion site.Per the event description, during the procedure, the stent arrived at the target position, but it was unintentionally released into the distal end of the vessel, and it did not cover the lesion site.The physician then released a new stent into the target position and completed the surgery.There was no patient injury reported.Additional information was received on 09-sep-2022 from the sales representative.The target vessel being treated was reported to be the right middle cerebral artery.Vessel characteristic was claimed to be normal.The complaint device was prepped and used as per the ifu.There was no obvious resistance between the microcatheter and the stent.The microcatheter used was a 150cm x 5cm prowler select plus (606s255x).The information indicated that the concomitant devices functioned as expected.The stent was unexpectedly released in the vessel and could not be withdrawn.There was no delay to the procedure.A non-sterile 4mm x 23mm enterprise 2 was returned contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and it was noted that only the introducer and guidewire components were returned for evaluation.No damages (i.E., kinks, elongations, or separated fragments) were observed on the returned components.The stent component was unexpectedly released in the vessel and remained implanted in the patient; therefore, no further evaluation could be performed and no contributing factors to the reported issue encountered during the procedure could be identified from the returned components.Additionally, the deployment difficulty related to the inaccurate placement cannot be evaluated through functional testing as it depends on procedural factors that cannot be replicated in the laboratory setting.This is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Other factors, such as device manipulation and vessel characteristics, may have contributed to the reported failure; with the limited information available, this cannot be conclusively determined.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6441633.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if stent positioning is not satisfactory, the stent may be recaptured and repositioned.The stent may be recaptured until the point where the proximal end of the stent positioning marker is aligned with the infusion catheter distal marker band (recapturability limit).If stent repositioning is required, gently advance the infusion catheter over the deployed stent (do not pull the stent back into the infusion catheter), reposition the system, and re-deploy the stent in the new location.Do not deploy the stent if it is not properly positioned in the vessel.Maintain adequate stent length (approximately 5 mm) on each side of the aneurysm neck to ensure appropriate neck coverage.Deployment difficulty was experienced, and the stent was inaccurately placed, which may have led to damage to healthy intima, possible side branch occlusion, and/or the need for additional intervention.In this case, a new stent was implanted in order to avoid patient injury.Also, with the issue of the stent not being properly aligned and not able to be withdrawn/ recaptured in order to correct its placement could result to the stent not covering the neck of the aneurysm, prolapsing into the aneurysm, or the need for additional procedure.Therefore, this event meets mdr reporting criteria with the classification of ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15103005
• MDR Text Key: 296579646
• Report Number: 3008114965-2022-00507
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6441633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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
• Patient Outcome(s): Required Intervention