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

Model Number UNKNOWN

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The study data reflects the investigators awareness that the study has several limitations by indicating that this study had a retrospective design and a small sample size from a single institution.In addition, the investigator acknowledged that this study did not show the results of a direct comparison between flow diverter deployment and the double lvis blue stenting technique and finally, nineteen aneurysms 76 percent were in the posterior circulation and giant, acutely ruptured fusiform aneurysms were also not included in this study.This indicates that the efficacy and safety results of this study may not be generalized to various locations and types of fusiform cerebral aneurysms.The double stenting technique using lvis blue stents for the treatment of fusiform cerebral aneurysms is effective and safe with a low rate of complications and a relatively high rate of favorable obliteration.This technique can be a good alternative treatment option for flow diverters.The interpreted results of this study reflect the expected demonstration of safety and performance and the identified awareness of this study design and small sample size limitation.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.A search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Ifu review additional information can be found in the ifu.Possible complications include but are not limited to the following: hematoma at the puncture site, perforation or dissection of the vessel(s), intravascular spasm, hemorrhaging, rupture or perforation of aneurysm, coil herniation, device migration, neurologic insufficiencies including stroke and death, ischemia, vascular occlusion, vessel stenosis, incomplete aneurysm occlusion, pseudoaneurysm formation, distal embolization, headache, infection.Reaction to contrast agents including severe allergic reactions and renal failure.Ban, seung pil, et al.Results of double low-profile visualized intraluminal support lvis blue stenting for the treatment of fusiform cerebral aneurysms.World neurosurgery 2022.

Event Description

As reported through the journal article titled results of double low-profile visualized intraluminal support lvis blue stenting for the treatment of fusiform cerebral aneurysms, intraprocedural thromboembolic complications occurred in 1 patient; 4 percent.The aim of this study was to analyze the clinical and angiographic outcomes of lvis blue 25 double stenting for fusiform cerebral aneurysms.We retrospectively reviewed patients who were treated with double lvis blue stenting for fusiform cerebral aneurysms in our institution between march 2016 and july 2020.Between march 2016 and july 2020, double lvis blue stenting was attempted in 25 fusiform cerebral aneurysms.Patient medical records and radiological images were carefully reviewed.The technical success rate was 100 percent 25 out of 25.Intraprocedural thromboembolic complications occurred in 1; 4 percent patient.In this case, in-stent thrombi were completely resolved with intravenous infusion of tirofiban, and no newly developed neurological deficits were observed.There were no deaths or delayed thromboembolic complications during the follow-up period.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92056
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15965791
• MDR Text Key: 305748219
• Report Number: 2032493-2022-00544
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/13/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female