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

Catalog Number ENCR402300

Device Problem Premature Activation (1484)

Patient Problem Vasoconstriction (2126)

Event Date 11/27/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(6).Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6577075.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

It was reported by a healthcare professional that a female patient underwent stent-assisted coil embolization of an anterior communicating artery aneurysm and experienced premature stent deployment during the procedure with subsequent vasospasm.The tip of the concomitant microcatheter (size/brand not specified) was placed in the target position and the 4mm x 23mm enterprise 2 no tip stent (encr402300/6577075) was pushed into the microcatheter.The stent prematurely released at the middle cerebral artery (mca); the reference marker on the delivery wire had not arrived at the y-connector.Vasospasm occurred, and her heart rate increased.It was stated that the blood velocity quickened.Antithrombotic drug was administered as treatment.The physician implanted a competitor stent at the target position and the procedure was completed.The procedure was prolonged about one hour due to the event.The patient is reportedly in stable condition.The returned procedural film was reviewed by sr.Medical affairs director and the assessment reads as follows: ¿the event description gives a clear view of what happened when the physician tried to place the enterprise stent.The images show the enterprise in a position distal to the target aneurysm and in the mca.The side cannot be determined from this single plane image.It is assumed the stent was delivered before the initiation of fluoroscopic guidance as the physician would not have expected the stent to be beyond the microcatheter before the pusher wire markers lined up with the y connector.The reason for the discrepancy in stent position and marker alignment cannot be determined based on images alone.No conclusions regarding the root cause of this event can be determined based on the information currently available.¿.

Manufacturer Narrative

Product complaint # (b)(4).Updated section on this medwatch report: b4, b5, g3, g6, h2, h10 and concomitant products.Section b5: additional information received indicated that a prowler select plus microcatheter (unknown product code & lot number) was used in conjunction with the complaint device.There was no resistance felt within the microcatheter nor was it necessary to remove the microcatheter.There was an adequate flush maintained through the devices.The device delivery system was successfully removed from the patient.Further clarification was received indicating that according to the physician, the prowler select plus microcatheter was a potential cause of the vasospasm.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that a female patient underwent stent-assisted coil embolization of an anterior communicating artery aneurysm and experienced premature stent deployment during the procedure with subsequent vasospasm.The tip of the prowler select plus microcatheter (unknown product code & lot number) was placed in the target position and the 4mm x 23mm enterprise 2 no tip stent (encr402300/6577075) was pushed into the microcatheter.The stent prematurely released at the middle cerebral artery (mca); the reference marker on the delivery wire had not arrived at the y-connector.Vasospasm occurred, and her heart rate increased.It was stated that the blood velocity quickened.Antithrombotic drug was administered as treatment.The physician implanted a competitor stent at the target position and the procedure was completed.The procedure was prolonged about one hour due to the event.The patient is reportedly in stable condition.Additional information received indicated that there was no resistance felt within the microcatheter nor was it necessary to remove the microcatheter.There was an adequate flush maintained through the devices.The device delivery system was successfully removed from the patient.Further clarification was received indicating that according to the physician, the prowler select plus microcatheter was a potential cause of the vasospasm.The returned procedural film was reviewed by a neurointerventionalist and the assessment reads as follows: ¿the event description gives a clear view of what happened when the physician tried to place the enterprise stent.The images show the enterprise in a position distal to the target aneurysm and in the mca.The side cannot be determined from this single plane image.It is assumed the stent was delivered before the initiation of fluoroscopic guidance as the physician would not have expected the stent to be beyond the microcatheter before the pusher wire markers lined up with the y connector.The reason for the discrepancy in stent position and marker alignment cannot be determined based on images alone.No conclusions regarding the root cause of this event can be determined based on the information currently available.¿ lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6577075.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Premature stent deployment necessitating additional intervention is a known potential procedural complication associated with the enterprise 2 vascular reconstruction device (vrd).The enterprise ifu states the following: track the stent through the infusion catheter to the tip and position the stent for deployment by aligning the stent positioning marker of the delivery wire with the target site.If stent positioning is satisfactory, carefully retract the infusion catheter, while maintaining the position of the delivery wire, to allow the stent to deploy across the neck of the aneurysm.The stent will expand as it exits the infusion catheter.The ifu also warns the user to never detach the stent if it is not properly positioned in the vessel or if the position of the infusion catheter delivering the embolic coils has been lost.Vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.This is a well-known potential complication with any invasive procedure during which devices are introduced into vessels.With the information provided, it is not possible to determine the root cause of the premature stent deployment.However, the event may have been related to a combination of multiple factors experienced in the clinical setting.There is no indication that the event is related to the device design or manufacturing process.The alleged premature stent deployment necessitated placement of a second stent to completely cover the aneurysm neck and maintain the coils within the confines of the target aneurysm.Furthermore, the premature stent deployment resulted in vessel spasm with the need for medical intervention to preclude permanent impairment/damage.This file will be reassessed if additional information becomes available.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint # (b)(4) the correct awareness date is 12/06/2021.

• Brand Name: ENTERPRISE2 4MMX23MM 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: 13042703
• MDR Text Key: 282489134
• Report Number: 3008114965-2021-00748
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402300
• Device Lot Number: 6577075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: PROWLER SELECT PLUS.; UNSPECIFIED MICROCATHETER.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female