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

Model Number	172524-LVISJ-C-PMA
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2032493-2022-00358
• Device Sequence Number: 17881688
• Product Code: QCA
• UDI-Device Identifier: 00842429100844
• UDI-Public: (01)00842429100844(11)191021(17)220930(10)191021537
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male