MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problem Material Separation (1562)

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

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter phone: (b)(6).The device remains implanted in the patient; therefore, no further investigation can be performed.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported that a patient underwent surgery of the vertebral artery stenosis where a 4mm x 23mm enterprise 2 (encr402312/ 6976992) vascular reconstruction device was used.Per event description, when the physician released the stent and withdrew the microcatheter during the procedure, the distal tip of the delivery wire ¿fell off¿ inside the patient and could not be removed.Additional information was received on 29-sep-2022 to clarify the event description.It was reported that the stent remains implanted in the patient hence no product return is possible.Two images were received, and the review was made by an independent physician the results are shown below: ¿the description provided is clear, after the enterprise stent was deployed the pusher wire came out without the distal tip.There is insufficient information provided in the description and images provided to understand the mechanism resulting in the event.In order to better understand the event additional information would be needed such as the following: whether the device deployed easily, if force was needed, if there was an angle in the pusher wire, if the tip navigated into a side branch etc.Therefore, it is not possible to understand the mechanism behind the fracturing of the tip.On the images provided the tip (visible coil) is seen proximal to the stent in the vertebral artery on the left side.It is unclear if there is more metal present and therefore, we cannot ascertain that it is only the radiopaque distal coil that fractured.This can be seen on a ct scan if need be.¿.

Manufacturer Narrative

Product complaint #: (b)(4).Complaint conclusion: it was reported that a patient underwent surgery of the vertebral artery stenosis where a 4mm x 23mm enterprise 2 (encr402312/ 6976992) vascular reconstruction device was used.Per event description, when the physician released the stent and withdrew the microcatheter during the procedure, the distal tip of the delivery wire ¿fell off¿ inside the patient and could not be removed.No other information was provided.Additional information was received on 29-sep-2022 to clarify the event description.It was reported that the stent remains implanted in the patient hence no product return is possible.The correct lot number of the enterprise 2 vrd was provided and listed in the narrative above.The submitted imaging were forwarded to the cerenovus senior medical affairs director for review.The assessment reading of the images performed by the senior medical affairs director is as follows: "the description provided is clear, after the enterprise stent was deployed the pusher wire came out without the distal tip.There is insufficient information provided in the description and images provided to understand the mechanism resulting in the event.In order to better understand the event additional information would be needed such as the following: whether the device deployed easily, if force was needed, if there was an angle in the pusher wire, if the tip navigated into a side branch etc.Therefore, it is not possible to understand the mechanism behind the fracturing of the tip.On the images provided the tip (visible coil) is seen proximal to the stent in the vertebral artery on the left side.It is unclear if there is more metal present and therefore, we cannot ascertain that it is only the radiopaque distal coil that fractured.This can be seen on a ct scan if need be¿.The device remains implanted in the patient; therefore, no further investigation can be performed.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.Fracture of the delivery wire is a potential issue that can occur with the use of the enterprise 2 vascular reconstruction device as stated in its instruction for use (ifu).With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the provided information, the mechanism behind the fracturing of the tip and causing separation cannot be determined at this time.However, this occurrence of a fractured wire carries the risk of the fractured part of the device to embolize which can result in an ischemia or an infarct.Therefore, this event meets the mdr reporting criteria.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.The file will be re-reviewed if additional information is received at a later date.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX23MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15632566
• MDR Text Key: 302006308
• Report Number: 3008114965-2022-00666
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6976992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability