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

Model Number UNKNOWN

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Event Description

As reported through the article titled " retreatment with a pipeline embolization device for recanalized aneurysms following stent-assisted coiling embolization", this case series presents a retrospective single-center analysis of patients with recanalized aneurysms who underwent retreatment using the ped between july and april, subsequent to stent-assisted coiling embolization.The study includes five female patients, whose relevant clinical data were recorded.All patients had aneurysms located in the internal carotid artery, comprising two blood blister-like aneurysms and two giant aneurysms.Prior to the retreatment, two lvis stents, two enterprise stents, and one solitaire stent were implanted.Patient #1 a 49-year-old woman underwent stent-assisted coiling (lvis) for a p-comm blood blister-like aneurysm at another hospital 5 months ago.She was admitted to our hospital for treatment of recurrent aneurysm, which was diagnosed during a computed tomography angiography (cta) scan performed 2 weeks ago.Dsa revealed a recurrent aneurysm with a maximum diameter of ~9.3 mm (figure 2a).The previous lvis stent and loose coils are shown in figures 2b, c, respectively.The aneurysm was retreated using a ped of 4.0 mm × 20 mm (medtronic, minneapolis, minnesota) and three coils.A complete occlusion of the recanalized aneurysm was achieved (figure 2d).The ped covered only the proximal end of the lvis stent (figures 2e, f).A 6-month follow-up cta indicated complete occlusion.

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The devices were implanted in the patients and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issues/events as described could not be confirmed.This report is related to a different mfr report number for lvis devices from this article.Ling, yuhui, et al."retreatment with a pipeline embolization device for recanalized aneurysms following stent-assisted coiling embolization." frontiers in neurology 14 (2023).

Manufacturer Narrative

H11: please note the original medwatch report was submitted incorrectly as section "b.1 report type" was selected as product problem (e.G.Defects/malfunctions).B1 was corrected by selecting only adverse event as the incident details indicated.Product problem (e.G.Defects/malfunctions) was not chosen in section b1 of this report.

Event Description

Please see h10 / h11.

• Brand Name: LVIS D
• 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
• MDR Report Key: 18253094
• MDR Text Key: 329549414
• Report Number: 2032493-2023-01086
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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?: Yes
• 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: 11/13/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/22/2024
• 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 Sex: Female