MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 4.5X23 (HDE); STENT

Model Number	213025-LVIS-D-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	10/03/2017
Type of Reportable Event	Death
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 physician stated that the hemorrhage from the rupture of the m1 artery was not related to the stent.The device performed as expected.The instructions for use (ifu) identifies hemorrhage and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that a patient was being treated for a high-grade (90%) stenotic atherosclerotic plaque in the left mca.After the first inflation with a balloon (non-microvention), there was significant improvement of flow; however, 80% stenosis remained.A second, larger balloon (non-microvention) was advanced and inflated at the same site.A post-dilatation angiogram revealed active contrast extravasation from a ruptured mca.The lvis stent was successfully deployed without complications at the bleeding site as treatment for the bleeding, followed by coil embolization and total occlusion of the m1 arterial segment.Follow-up angiogram demonstrated total resolution of the extravasation, and the balloon and microcatheter were removed.No further therapy was administered to the patient per the family's request due to the poor prognosis.The clinical research nurse reported that the patient died; however, the death was a result of the procedure and was not caused by the lvis.

• Brand Name: LVIS 4.5X23 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7023178
• Report Number: 2032493-2017-00283
• Device Sequence Number: 1051021
• Product Code: NJE
• UDI-Device Identifier: 00812636022215
• UDI-Public: (01)00812636022215(11)161019(17)190930(10)16101922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: 213025-LVIS-D-HDE
• Device Lot Number: 16101922
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: Death
• Patient Age: 80 YR