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

Model Number 172524-CASJ

Device Problem Retraction Problem (1536)

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

Event Date 04/06/2022

Event Type  Injury  

Event Description

It was reported that the lvis jr stent was used to treat a subarachnoid hemorrhage and aneurysm at the bifurcation of the left middle cerebral artery.When the stent was introduced into the left distal brain, the 3.5 x 23mm lvis jr stent did not fully open.The stent was wrapped by thrombus and could not be removed.The doctor chose to deploy and detach the stent.After balloon dilatation, angiogram was still poor and the doctor decided to introduce a 4.0 x 30 stent.A subsequent angiography showed that the blood flow recovered.The operation was then completed.The patient's neurological signs were normal.The patient is fine.

Manufacturer Narrative

A search for non-conformance's 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 cannot be verified.

• 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: 14940797
• MDR Text Key: 295401201
• Report Number: 2032493-2022-00256
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103340
• UDI-Public: (01)00842429103340(11)190923(17)220831(10)19092354K
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 172524-CASJ
• Device Lot Number: 19092354K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 70 KG