MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF403000

Device Problem Break (1069)

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

Event Date 11/08/2023

Event Type  Injury  

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 3008114965-2023-00880.

Event Description

It was reported, via email, that two enterprise2 4mmx30mm no tip (enf403000/8129994) stents were used for an endovascular embolization procedure, during which the user reported stent deployment difficulty-inaccurate placement for the first used stent, which resulted in the stent navigating into the aneurysm.This stent was removed.The user also reported a failed stent placement attempt for the second enterprise2 stent, which was also removed.An angiography confirmed no injury was done to the patient as a result of the events.The aneurysm embolization procedure was then aborted.A new endovascular embolization procedure was ¿programmed¿, where the physician utilized a competitor stent instead.The event was reported as such: ¿endovascular embolization attempt with enterprise2 (x2) used.After enterprise2 placement deployment, the stent navigated to aneurism.Stent was removed.A second attempt to embolization with enterprise2 failed.The stent was removed.A cerebral angiography was performed to review, no damage on artery.No complication or lacerations in artery confirmed.Due this incident the aneurism embolization was abort.Cerebral angiography performed completely to confirm any lessons.No complications.A new endovascular embolization procedure was programmed physician used competitor stent (atlas stent).¿ no further information was made available at the time of this review.

Manufacturer Narrative

Product complaint#: (b)(4).The device was not returned for analysis; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot: 8129994.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Stent deployment difficulty-inaccurate placement may lead to damage of healthy intima, possibly side branch occlusion and/or the need for an additional intervention.In this case, the stent navigated into the aneurysm, requiring a modification to the surgical procedure, which was to remove the stent and attempt the placement of a new stent.It is currently unknown if there were any alleged quality issues related to the second enterprise 2 stent used, however, the placement attempt was unsuccessful.The failed attempt could have been related to the patient anatomy, operator technique and appropriate device selection.Both events resulted in a modified surgical procedure and ultimately, the second failed attempt resulted in a delay of the surgical procedure.It is unknown if the events resulted in extended hospitalization, exacerbation of the patient's condition, or a time delay that presented high risk to the patient.Therefore, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of a ¿serious injury¿.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 NO TIP
• 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: 18212035
• MDR Text Key: 329064663
• Report Number: 3008114965-2023-00881
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075387
• UDI-Public: 10886704075387
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENF403000
• Device Lot Number: 8129994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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: ENTERPRISE2 4MMX30MM NO TIP.
• Patient Outcome(s): Required Intervention