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

Catalog Number	ENCR403012
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional 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.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.
Event or Problem Description
As reported by the field, during an endovascular embolization, an enterprise2 4mmx30mm intracranial stent (encr403012, 8848352) became impeded in the hub of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not advance any more.The physician removed the stent and microcatheter (mc) from the patient and switched to a new stent and a new microcatheter to complete the procedure.There was no patient injury reported.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during an endovascular embolization, an enterprise2 4mmx30mm intracranial stent (encr403012, 8848352) became impeded in the hub of a prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not advance any more.The physician removed the stent and microcatheter (mc) from the patient and switched to a new stent and a new microcatheter to complete the procedure.There was no patient injury reported.No additional information is available.A non-sterile enterprise2 4mmx30mm was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed and it was noted that the stent component was found detached inside the luer hub of the concomitant microcatheter.No appearance of damages were noted on the delivery wire and the introducer.The issue reported regarding the stent being impeded in the impeded in the hub of the microcatheter could not be evaluated due to the detached condition of the stent.This component must still be attached to the delivery wire and inside the introducer to perform a functional analysis; however, this condition suggests that the enterprise introducer was not fully seated in the hub of the microcatheter, causing the stent to expand in the microcatheter's hub, resulting in the stent component being unable to advance further, where push/pull force was applied sufficiently to disengage the stent from the delivery wire.However, with the amount of information available this only remains speculative.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8848352.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: ¿ confirm the tip of the delivery wire is entirely within the introducer.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX30MM
• Common Device Name: 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: 20224901
• Report Number: 3008114965-2024-00905
• Device Sequence Number: 17952074
• Product Code: NJE
• UDI-Device Identifier: 10886704075370
• UDI-Public: (01)10886704075370(17)261228(10)8848352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 8848352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 09/30/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/26/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT PLUS 150/5CM
• Patient Sex: Unknown