MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 4.0X22 (HDE); STENT

Model Number	212922-LVIS-D-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The stent was implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.There was no reported device malfunction.The instructions for use (ifu) identifies thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that stent-assisted coiling of a supraclinoid left internal carotid artery aneurysm was performed.The patient was premedicated with dual antiplatelet therapy (aspirin and clopidogrel).Heparin was administered following sheath placement and at one-hour intervals (9000u total).The lvis stent was successfully deployed without incident and coils were implanted in the aneurysm.Angiograms taken after coil placement demonstrated a subtle filling defect suggestive of acute in-stent thrombosis in the distal cavernous left internal carotid artery (lica).A 180 mcg/kg iv bolus of eptifibatide was administered.After ten (10) minutes, a repeat angiogram noted nearly complete clot lysis.A 2 mcg/kg/min iv of eptifibatide was continued for twelve (12) hours to maintain stent patency.

• Brand Name: LVIS 4.0X22 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7277414
• Report Number: 2032493-2018-00030
• Device Sequence Number: 1993616
• Product Code: NJE
• UDI-Device Identifier: 00816777026002
• UDI-Public: (01)00816777026002(11)170322(17)200229(10)17032221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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: Other
• Device Expiration Date: 02/29/2020
• Device Model Number: 212922-LVIS-D-HDE
• Device Lot Number: 17032221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR