MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X17 (HDE); STENT

Model Number	172014-LVISJ-C-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893)
Date of Event	06/01/2017
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.Two procedure-related images were provided for evaluation and reviewed.One 3-d magnetic resonance angiography image was provided, but not labeled with any anatomical references.A fluoroscopic digital subtraction image was provided, which demonstrates a deployed stent adjacent to a coil mass.No contrast is visible; therefore, an assessment for proper apposition to the vessel wall cannot be made.There are no obvious deficiencies noted on the stent, and it appears to be fully expanded.No other information can be gathered from the image.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 pathology report stated that the hemorrhage did not appear to be related to the stent.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 stent-assisted coiling treatment was performed on an unruptured but growing right middle cerebral artery aneurysm via the right internal carotid artery.There were no technical problems during the case; however, the patient died four (4) days after the procedure.The post mortem exam showed the stent, coils, and aneurysm were intact.The pathologist stated that the pattern of the marked subarachnoid hemorrhage was a hypertensive-type of deep basal ganglia hemorrhage, which was located in the same hemisphere as the treated segment, but did not appear to be related to the devices.The report stated the exam was negative for gross disruption of the middle cerebral artery in the area of prior coiling.

• Brand Name: LVIS JR 2.5X17 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6799193
• Report Number: 2032493-2017-00199
• Device Sequence Number: 19025707
• Product Code: NJE
• UDI-Device Identifier: 00812636020136
• UDI-Public: (01)00812636020136(11)161101(17)191031(10)16110132
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/17/2017

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: Other
• Device Expiration Date: 10/31/2019
• Device Model Number: 172014-LVISJ-C-HDE
• Device Lot Number: 16110132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/16/2017
• 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