MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF403012

Device Problem Retraction Problem (1536)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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 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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00294.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, the tip of an enterprise2 4mmx23mm intracranial stent (enf402312, 7507670) pre-maturely deployed in a phenom 21 of medtronic microcatheter (mc).The stent was lost as the assistant tried to save it for complaint report.The rest of the device will be returned for further analysis.On the user¿s second try, the physician experienced recapture failure with enterprise2 4mmx30mm (enf403012, 6451023).The user tried to recapture the stent but was not able to.Therefore, he removed the stent and the mc from the patient's body.The physician used a same like product.Eventually the procedure was successfully finished.There was no patient injury reported.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, the tip of an enterprise2 4mmx23mm intracranial stent (b)(6) pre-maturely deployed in a phenom 21 of medtronic microcatheter (mc).The stent was lost as the assistant tried to save it for complaint report.The rest of the device will be returned for further analysis.On the user¿s second try, the physician experienced recapture failure with enterprise2 4mmx30mm (b)(6).The user tried to recapture the stent but was not able to.Therefore, he removed the stent and the mc from the patient's body.The physician used a same like product.Eventually, the procedure was successfully finished.There was no patient injury reported.No additional information is available.The device was discarded; therefore, no further investigation can be performed.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 reported inability to recapture the stent could not be evaluated without the return of the introducer and stent.Inability to recapture is a known potential product issue associated with the use of the enterprise2 stent.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting should it be encountered during use.The ifu states the following: ¿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.Note: when advancing the infusion catheter over the stent during recapture, it may be necessary to keep the stent stable with tension on the delivery wire.Caution: if resistance is felt while recapturing the stent, do not continue to recapture the device.Withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.Caution: the stent may be fully recaptured once.¿ 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 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.

• Brand Name: ENTERPRISE2 4MMX30MM
• 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 ; 3035526892
• MDR Report Key: 16933765
• MDR Text Key: 316280025
• Report Number: 3008114965-2023-00295
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075370
• UDI-Public: 10886704075370
• 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
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF403012
• Device Catalogue Number: ENF403012
• Device Lot Number: 6451023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Treatment: ENTERPRISE2 4MMX23MM.; PHENOM 21 OF MEDTRONIC MICROCATHETER.