MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR; INTRACRANIAL COIL-ASSIST STENT

Model Number 172014-CASJ-C-CN

Device Problem Activation Failure (3270)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/14/2023

Event Type  Injury  

Event Description

It was reported that the lvis jr stent was used to treat a patient with an anterior communicating artery (aca) aneurysm.Reportedly, the stent did not completely open when released after placement of coils and thrombus developed immediately.A snare device was used to remove the the thrombus and the stent from the patient.Another different brand stent was used to complete the case.No report of harm or injury to the patient, who was reported to be fine.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for analysis; however, one fluoroscopy image was provided and is under review.Upon completion of investigation, microvention, inc., will submit a supplemental report.

Manufacturer Narrative

Additional information: h6, h10 (investigation findings).Investigation findings: visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu, following is taken from the english version): potential complications possible complications include but are not limited to the following: ¿ hematoma at the puncture site ¿ perforation or dissection of the vessel(s) ¿ intravascular spasm ¿ hemorrhaging ¿ rupture or perforation of aneurysm ¿ coil herniation ¿ device migration ¿ neurologic insufficiencies including stroke and death ¿ ischemia ¿ vascular occlusion ¿ vessel stenosis ¿ incomplete aneurysm occlusion ¿ pseudoaneurysm formation ¿ distal embolization ¿ headache ¿ infection ¿ reaction to contrast agents including severe allergic reactions and renal failure 20.If lvis device positioning is satisfactory, carefully retract the microcatheter and advance the delivery wire together, to allow the lvis device to deploy across the neck of the aneurysm.Ensure the device proximal radiopaque end markers are approximately 7 mm proximal to the aneurysm neck to ensure an adequate landing zone.The lvis device will expand and total length may foreshorten up to 60% from its undeployed length (refer to tables 1) as it exits the microcatheter.Ensure microcatheter is retracted and clear from the proximal flared ends.Note: visualize and refer to the implant radiopaque end markers to maintain adequate implant length, approximately 7 mm on each side of the aneurysm neck or target location to ensure appropriate neck coverage.Warning: do not detach the lvis device if it is not properly positioned in the parent vessel.Observe the delivery wire distal tip to assure it remains within the desired location of the parent vessel.21.Prior to removing the delivery wire and if necessary, carefully position the microcatheter distal to the lvis device to maintain access through the lvis device.Remove and discard the delivery wire.Warning: the lvis device delivery wire should not be utilized as a guide wire.Do not torque the lvis device.A torque device should not be used.Investigation conclusion: only two images are provided.First image is a low-resolution picture of the device on the bench after removal.It is in large part covered with clot.One end is open (presumably the distal end).The investigation cannot comment on the mid-portion as it is covered with clot.The other end does not appear open.Second image is an oblique roadmap of the ica (the side is not labeled, but it looks like the left).There is a guiding catheter in the distal petrous ica.There are coils in a medium-sized acom aneurysm.The distal part of the lvis jr.Is open distally in the a2 segment of the aca.The stent is not open at all beginning in the acom segment itself (where there is a 90-degree bend), all the way back to the distal 1/3 of the a1 segment.Due to the low quality of the image, the investigation cannot determine if there is a microcatheter and, if there is, what its relationship to the lvis jr.Would be.The cause for the non-opening of the proximal half of the lvis jr.Is not seen on these images.The 90-degree curve at the acom may have contributed.

• Brand Name: LVIS JR
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16584511
• MDR Text Key: 311702976
• Report Number: 2032493-2023-00630
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103302
• UDI-Public: (01)00842429103302(11)220617(17)250531(10)0000207198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1700013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 172014-CASJ-C-CN
• Device Lot Number: 0000207198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 55 KG