MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL SUPPORT DEVICE

Model Number LEV3522-MVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/02/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance 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 implanted in the patient and not provided to the manufacture for evaluation.Procedural or post procedural images were not provided.The event as described could not be confirmed.

Event Description

It was reported that an lvis evo stent was implanted in the right posterior circulation on (b)(6) 2022.The patient had been previously treated on (b)(6) 2022 for a ruptured basilir tip aneurysm with an lvis evo stent and 29 coils in the right posterior; they also received two external ventricular drains at that time.Approximately 30 minutes after implantation of the second stent, it was observed that both stents thrombosed.Tirofiban was administered through the microcatheter.The stents were observed to be open, but clots were visible.The procedure was ended and controlled anticoagulants were administered.The patient was still intubated.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; professor-arneth-strasse 2b; lichtenfels, 96215 ; GM 96215
• MDR Report Key: 15229022
• MDR Text Key: 297947707
• Report Number: 2032493-2022-00319
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429103517
• UDI-Public: (01)00842429103517(11)220204(17)250131(10)0000151542
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/02/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: LEV3522-MVE
• Device Lot Number: 0000151542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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; Other
• Patient Sex: Female