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

Model Number ENF402312

Device Problem Premature Activation (1484)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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

As reported by the field, during a stent assist coil embolization, a 4mm x 23mm enterprise2 intracranial neurovascular stent (enf402312, 7107418) was pre-maturely deployed on the prowler select plus microcatheter (mc).When the assistant nurse tried to take the stent out of the catheter hub, it bounced out.The nurse and physician tried to find the stent on the floor but couldn't find it.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, a 4mm x 23mm enterprise2 intracranial neurovascular stent (enf402312, 7107418) was pre-maturely deployed on the prowler select plus microcatheter (mc).When the assistant nurse tried to take the stent out of the catheter hub, it bounced out.The nurse and physician tried to find the stent on the floor but couldn't find it.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile 4mm x 23mm enterprise2 intracranial neurovascular stent was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the introducer was not returned for evaluation.The delivery wire was inspected, and it was found in good condition.The distance between delivery wire tip and reference marker was measured and it was confirmed to be within specifications.As stated in the event description, the stent component was not returned since it got lost during the procedure.A device history record (dhr) was performed, and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.The customer complaint that the stent prematurely deployed cannot be evaluated through functional testing.Without the components, it is not possible to identify device potential contributing factors that may have resulted in the observed failure mode.The customer complaint was confirmed since the stent was already deployed and not returned for evaluation, however, with the evidence available, the root cause remains speculative.It is possible that the introducer may have not been fully seated in the hub of the microcatheter and that the rhv locking ring was not tightened, causing the stent to ¿bounce out¿.Clinical and procedural factors, including device manipulation may have contributed to the reported failure.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendation: the introducer must be properly engaged with the infusion catheter hub to enable stent introduction into the infusion catheter.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15876768
• MDR Text Key: 304458025
• Report Number: 3008114965-2022-00783
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075356
• UDI-Public: 10886704075356
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF402312
• Device Catalogue Number: ENF402312
• Device Lot Number: 7107418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2022
• 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