MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENCR403912
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
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 e1.Initial reporter phone: (b)(6).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 4mmx39mm intracranial stent (encr403912, 8697571) became impeded in a prowler select plus 150/5cm microcatheter hub (606s255x, 31295078) and could not advance any more.After several attempts, the stent still could not be pushed into the microcatheter (mc).The physician removed the microcatheter and the stent from the patient and found that tip of the stent was kinked/bent.New devices were switched to complete the surgery.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint (b)(4) updated sections on this med watch: section b5: additional event information received on 26-sep-2024 indicated that they were not able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.There were no procedural delays due to the event.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).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).Complaint conclusion: as reported by the field, during an endovascular embolization, an enterprise2 4mmx39mm intracranial stent (encr403912, 8697571) became impeded in a prowler select plus 150/5cm microcatheter hub (606s255x, 31295078) and could not advance any more.After several attempts, the stent still could not be pushed into the microcatheter (mc).The physician removed the microcatheter and the stent from the patient and found that tip of the stent was kinked/bent.New devices were switched to complete the surgery.There was no patient injury reported.Additional event information received on 26-sep-2024 indicated that they were not able to torque the device.There was no evidence of physical material within the device.The microcatheter did not kink/bent.There was no excessive force used with the devices.There were no procedural delays due to the event.A non-sterile enterprise2 4mmx39mm intracranial stent was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the stent was detached from the delivery unit.The distal end of the delivery wire was broken and missing.Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The delivery wire had multiple kinked conditions.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 issue reported regarding the stent being impeded in the microcatheter could not be evaluated due to the detached condition of the stent.In order to perform a functional test, the stent must be attached to the delivery wire and inside the introduce; however, the damages on the distal end of the delivery wire suggest that excessive force was inadvertently applied during the device advancement which ultimately led to the damages found on the delivery wire.Based on this, the customer complaint was confirmed.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.The stent detachment was not originally reported and the exact time of occurrence cannot be determined; therefore, this is not considered related to the issue reported.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.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during the removal of the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Confirm the tip of the delivery wire is entirely within the introducer.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 4MMX39MM
• 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: 20301375
• Report Number: 3008114965-2024-00940
• Device Sequence Number: 21028577
• Product Code: NJE
• UDI-Device Identifier: 10886704075394
• UDI-Public: (01)10886704075394(17)261228(10)8697571
• 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,Followup
• Report Date (Section B): 11/08/2024

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: ENCR403912
• Device Lot Number: 8697571
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 10/31/2024; 11/07/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 09/27/2024; 11/04/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: Asian