MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23; INTRALUMINAL SUPPORT DEVICE

Model Number 172020-LVISJ

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101); Vascular System (Circulation), Impaired (2572)

Event Date 12/03/2019

Event Type  Death  

Manufacturer Narrative

A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The stent was implanted and the delivery system was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies vascular occlusion, vessel stenosis, and neurologic insufficiencies including stroke and death as potential complications associated with the use of the device.

Event Description

It was reported that stent-assisted coil embolization was performed.After access through tortuous anatomy, the lvis jr.Stent was successfully deployed from the left a1 to the right a2 and imaging confirmed full stent expansion.Three coils were then successfully placed at the treatment site without incident.Final procedure images demonstrated a clot in the middle of the stent.A bolus of integrilin was administered and tpa was delivered directly to the clot.As the clot was starting to dissolve, a spontaneous bleed was discovered at the p-com where no interventional work was done or devices had been placed.Integrilin and heparin were reversed, without success.Multiple devices were then used to stop bleeding, also without success.It was reported that the patient had insufficient blood flow to the left hemisphere of the brain at that point.The patient is reported to have expired.The exact date and cause of the patient's death is unknown.

• Brand Name: LVIS JR 2.5X23
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9541992
• MDR Text Key: 173442408
• Report Number: 2032493-2020-00001
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2019

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: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 172020-LVISJ
• Device Lot Number: 19010954J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention; Disability
• Patient Age: 63 YR