MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRALUMINAL DEVICES

Model Number 212525-CAS-D-CN

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

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.The device remains implanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported during treatment, after the stent was deployed, the doctor found that the guide wire of the stent was broken in the blood vessel when withdrawing the guide wire at the front of the stent.Then the doctor took out the guide wire and used the embolectomy stent.There was no reported harm or injury to the patient.

Manufacturer Narrative

Additional information / b5: additional information with images received on 2/02/2023.The provided information indicated, after the stent was deployed, the doctor found that the distal guide wire was fractured in two pieces in the patient.When the stent guide wire was withdrawn, the doctor removed the broken guide wire with the embolic stent.The stent was deployed in the intended location.There was no reported harm or injury to the patient.Visual analysis: the distal end of the pusher appeared perpendicular to the lumen of the microcatheter after being retrieved during the procedure for image 2, 4.The pusher appeared to have been advanced out of the microcatheter for examination and appeared broken at the distal end, along with a detached pusher body coil for image 1, 3.Images 5 and 6 appear to be screenshots of a message chain containing the four images previously referenced.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.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of 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 vessels, 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 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 percent from its undeployed length 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.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: no products were returned for evaluation, but six images of the device post-procedure were provided.The images showed the pusher broken at the distal end and the pusher body coil detached, which is consistent with the alleged product issue.However, without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16240936
• MDR Text Key: 308093242
• Report Number: 2032493-2023-00538
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020013
• UDI-Public: (01)00812636020013(11)210325(17)240229(10)21032554J
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 212525-CAS-D-CN
• Device Lot Number: 21032554J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female