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

Model Number UNKNOWN

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

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The device was implanted and a portion of the device may have been discarded at the user facility and not returned to the manufacturer for evaluation.Additional information was requested and not provided.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.The event as described could not be confirmed.If additional information is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies intra or post procedural thrombus and hemorrhage as potential complications associated with use of the device.

Event Description

As reported through the journal article titled, ¿utility of low-profile visualized intraluminal support (lvis) stent for treatment of acutely ruptured bifurcation aneurysms: a single-center study¿, between (b)(6) 2021 a total of 41 patients with acutely ruptured intracranial aneurysms arising at the bifurcation were treated with lvis stent-assisted coiling in one hospital.The angiographic results available for the 36 patients during the follow-up period revealed complete occlusion was achieved in 30 patients (83.3%) and residual neck in six patients.All procedures were completed.Intraoperative thromboembolism with in-stent thrombosis incidence was observed in two cases (4.9%), and this was successfully resolved by intra-arterial tirofiban infusion without the occurrence of associated neurological deficits after treatment.Intraoperative hemorrhage occurred in one case (2.4%), and this incidence was successfully managed by neutralizing heparin, rapidly packing small coils for dense embolization to achieve hemostasis, and finally deploying the stent successfully, without substantial neurological deterioration after treatment.Postoperative complications, such as thromboembolic or rebleeding events, were not observed.A total of 41 cases of acutely ruptured bifurcation aneurysms were treated with lvis stent-assisted coiling in our cohort.All of the lvis devices were completely deployed.Notably, 83.3% of the aneurysms were occluded completely, and 92.7% of cases had good clinical outcomes.These findings suggest that using the lvis stent is safe and feasible for patients with acutely ruptured bifurcation aneurysms.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16754125
• MDR Text Key: 313478697
• Report Number: 2032493-2023-00667
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• PMA/PMN Number: : P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2023

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?: No
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention