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

Model Number	212517-LVIS-D-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information was received.Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.
Event or Problem Description
It was reported through the lvis pas clinical study, there was incomplete open of the intraluminal support sent device proximal to the aneurysm.On follow-up angiography, the proximal stent was noted not to be fully opened.Given that no alteration in flow was noted, further pushing on the partially open stent was no performed.The patient did not require other treatment/intervention as a result of the malfunction.This technical event is not associated with any adverse event and did not lead to a serious adverse device effect (sade).
Additional Manufacturer Narrative
Additional information was received as provided in section b5 and h6.
Event or Problem Description
Additional information was received indicating the subject underwent index procedure of stent assisted coil embolization of a ruptured basilar tip aneurysm on (b)(6) 2019.On (b)(6) 2019 subject experienced right-sided drift, mild weakness, and dysarthria.Mri showed a small left thalamic ischemic stroke likely from a perforator occlusion.Cta showed patent stent.Subject was admitted to the neuro icu and, next day morning neurological symptoms improved, and subject was transferred to floor; and continued treatment with aspirin and plavix.The event was adjudicated by cec as study device and study procedure related.
Additional Manufacturer Narrative
Corrections were made to the following sections: b1; b2; h1.
Event or Problem Description
A supplemental report is being submitted to correct the following sections: b1; b2; h1.

• Brand Name: LVIS D
• Common Device Name: 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: 22057377
• Report Number: 2032493-2025-90163
• Device Sequence Number: 8308809
• Product Code: QCA
• UDI-Device Identifier: 00842429100875
• UDI-Public: (01)00842429100875(11)180119(17)201231(10)18011956FM
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 212517-LVIS-D-PMA
• Device Lot Number: 18011956FM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 02/05/2026; Not provided
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 02/23/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown