MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF0925
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00593.
Event or Problem Description
As reported by the field, during a surgical procedure for the communicating aneurysm, catheterization of the right a2 segment using a prowler microcatheter (mc) and a terumo 16'-90 °was used.When deployment of the intracranial, the stents of two 4mmx23mm enterprise2 no tip (enc402300, 11193908) and (enc402300, 5711204) got released inside the catheter and so it was not possible to recapture them anymore.A third enterprise stent delivery system (enc403012, 1161318) was used with success.The procedure was completed without any complication for the patient.The patient had a scanner and mri as part of a headache assessment associated with a phasic disorder that had been evolving for several weeks.The images show a giant aneurysm partially thrombosed of the left sylvic bifurcation, responsible for a left frontotemporal peri-lesional edema explaining the semiology.It was also fortuitously evidenced an aneurysm of the anterior communicating complex of about 10 mm.On (b)(6) 2020, the patient underwent a temporo-sylvic bypass by anastomosis between the left superficial artery and the temporal branch of the left middle cerebral artery allowing the exclusion of the giant aneurysm by clip placement.In view of this long and complicated intervention, the management of the communicating aneurysm is done later by endovascular route and placement of coils and an intracranial stent at the relatively wide aneurysm neck.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch report: g3, g6, h2, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a surgical procedure for the communicating aneurysm, catheterization of the right a2 segment using a prowler microcatheter (mc) and a terumo 16'-90 °was used.When deployment the intracranial, the stents of two 4mmx23mm enterprise2 no tip (enc402300, 11193908) and (enc402300, 5711204) got released inside the catheter and so it was not possible to recapture them anymore.A third enterprise stent delivery system (enc403012, 1161318) was used with success.The procedure was completed without any complication for the patient.The patient had a scanner and mri as part of a headache assessment associated with a phasic disorder that had been evolving for several weeks.The images show a giant aneurysm partially thrombosed of the left sylvic bifurcation, responsible for a left frontotemporal peri-lesional edema explaining the semiology.It was also fortuitously evidenced an aneurysm of the anterior communicating complex of about 10 mm.On august 2020, the patient underwent a temporo-sylvic bypass by anastomosis between the left superficial artery and the temporal branch of the left middle cerebral artery allowing the exclusion of the giant aneurysm by clip placement.In view of this long and complicated intervention, the management of the communicating aneurysm is done later by endovascular route and placement of coils and an intracranial stent at the relatively wide aneurysm neck.The device was not returned for analysis; therefore, no product investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of the lot 11193908 the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint of ¿stent - deployment difficulty-premature/in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Premature stent deployment in microcatheter is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device in the intracranial arteries.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 4MMX23MM NO TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11019379
• Report Number: 3008114965-2020-00592
• Device Sequence Number: 2684306
• Product Code: NJE
• UDI-Device Identifier: 10878528009648
• UDI-Public: 10878528009648
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 10/28/2022
• Device Model Number: 641CF0925
• Device Catalogue Number: ENC402300
• Device Lot Number: 11193908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTERPRISE2 4MMX16MM NO TIP.; PROWLER MICROCATHETER.; TERUMO 16'-90 INTERVENTION SYSTEM.