MAUDE Adverse Event Report: MICROVENTION, INC LVIS JR. 3.5X23; INTRACRANIAL COIL-ASSISR STENT

Model Number 172524-LVISJ-C-PMA

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

It was reported that during treatment of a wide neck basilar anuerysm using a y-stent technique.The 1st lvis jr stent was placed in the right pca and landed the stent proximally in the basilar artery.A 45 degree angled microcatheter was used to deliver the 2nd lvis jr in the left pca artery using a trans-cell approach through the 1st deployed lvis jr stent.After the 2nd stent was deployed in a y configuration, the microcatheter had what appeared to be a lot of forward load in it causing the microcatheter and stent to advance distally through the 2nd deployed lvis jr stent body.The physician pulled the microcatheter proximally in the basilar artery and attempted to use the lead wire from the pusher to cross the y stents.When he pulled the implant pusher to remove the lead wire it appeared to get entangled in the 2nd lvis jr stent.It was thought that just the implant lead wire was pulled back through and into the proximal basilar artery, but when the wire was removed, the 2nd lvis jr came out of the patient along with the pusher wire.The left pca artery was re-accessed with a microcatheter and deployed another 3.5 x 23 lvis jr stent.This attempt was successful.There was no report of harm or injury to the patient.

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 was not returned to the manufacturer for analysis.Therefore, the alleged product issue could not be confirm.If the device or additional information is received, microvention inc will issue a supplemental report.The instructions for use (ifu) identifies device migration as potential complications associated with use of the device.Ifu precautions indicate "exercise caution when crossing the deployed/detached lvis device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.".

• Brand Name: LVIS JR. 3.5X23
• Type of Device: INTRACRANIAL COIL-ASSISR STENT
• 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: 15332533
• MDR Text Key: 305279261
• Report Number: 2032493-2022-00358
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429100844
• UDI-Public: (01)00842429100844(11)191021(17)220930(10)191021537
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2022

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 Model Number: 172524-LVISJ-C-PMA
• Device Catalogue Number: 172524-LVISJ
• Device Lot Number: 191021537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 74 YR
• Patient Sex: Male