MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX39MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF1230

Device Problems Retraction Problem (1536); Failure to Advance (2524)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was not returned for investigation; therefore, no further analysis can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of lot 6153193.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, during a stent-assisted coil embolization of an aneurysm, the complaint device, a 4mm x 39mm enterprise 2 ((b)(4)) was used but it became stuck on an unspecified microcatheter (mc).It was difficult to remove the complaint device, therefore, it was removed together with the microcatheter.The procedure was completed with another new microcatheter and stent.No patient injury was reported.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that the introducer was fully seated and secured in the hub.The user was able to torque the device.There was no evidence of physical material within the device.It was confirmed that the resistance was felt inside the microcatheter.No excessive force was applied to the device.The delivery wire did not snag or get caught on the stent.There was no damage to the stent when removed from the patient.The target vessel/lesion being treated was the internal carotid artery.

Manufacturer Narrative

Product complaint #(b)(4).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 stent-assisted coil embolization of an aneurysm, the complaint device, a 4mm x 39mm enterprise 2 (enc403900, 6153193) was used but it became ¿stuck¿ on an unspecified microcatheter (mc).It was difficult to remove the complaint device, therefore, it was removed together with the microcatheter.The procedure was completed with another new microcatheter and stent.No patient injury was reported.Additional information received indicated that the introducer was fully seated and secured in the hub.The user was able to torque the device.There was no evidence of physical material within the device.It was confirmed that the resistance was felt inside the microcatheter.No excessive force was applied to the device.The delivery wire did not snag or get caught on the stent.There was no damage to the stent when removed from the patient.The target vessel/lesion being treated was the internal carotid artery.The device was not returned for investigation; therefore, no further analysis can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting, and packaging of lot 6153193.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Impeded in microcatheter and withdrawal difficulty are known potential issues associated with the use of the device.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.The instructions for use (ifu) instructs to advance the delivery wire to transfer the stent from the introducer into the infusion catheter.Warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 4MMX39MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12331615
• MDR Text Key: 267051128
• Report Number: 3008114965-2021-00393
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009662
• UDI-Public: 10878528009662
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 641CF1230
• Device Catalogue Number: ENC403900
• Device Lot Number: 6153193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/31/2021; 12/24/2021
• Supplement Dates FDA Received: 09/21/2021; 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: UNSPECIFIED MICROCATHETER