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

Model Number	212517-LVIS-D-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the lvis pas clinical study that during the procedure, the physician noted complication of intraoperative aneurysm rupture.The rupture was controlled with dense packing.Per (b)(6) 2016 progress note: "patient has some degree of coronary artery disease (cad).Echocardiogram overall had normal left ventricular systolic function." on (b)(6) 2016 discharge summary: "patient is neurologically intact, and will be discharge to home." subject informed site by telephone call encounter on (b)(6) 2017 had ct imaging, which showed no subarachnoid hemorrhage (sah); mra noted no significant aneurysm filling.Subject exited study on (b)(6) 2025, as there was no scheduled follow up.The adverse event has been adjudicated by a clinical evaluation committee (cec) as related to the study device and to the procedure.
Additional Manufacturer Narrative
The device was implanted in the patient and remains implanted.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.
Additional Manufacturer Narrative
Additional information was received as provided in section b5 and h6 (health impact code).
Event or Problem Description
Additional information was received indicating development of a small right frontal subdural hygroma likely due to small defect in the arachnoid.Patient is asymptomatic and underwent subduro-peritoneal.Event resolved without sequelae and was adjudicated by cec as study device and study procedure related.

• 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: 21878559
• Report Number: 2032493-2025-90096
• Device Sequence Number: 18300688
• Product Code: QCA
• UDI-Device Identifier: 00812636022192
• UDI-Public: (01)00812636022192(11)160923(17)190831(10)16092345
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 02/23/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 212517-LVIS-D-PMA
• Device Lot Number: 16092345
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2016
• 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: Required Intervention
• Patient Sex: Unknown