MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23 (HDE); LVIS JR.

Model Number	213025-LVIS-D-HDE
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	08/16/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it remains within the patient.(b)(4).
Event or Problem Description
It was reported the patient presented with a ruptured sah.It was determined that the right artery was the vessel that most likely ruptured due to previous imaging.A duo 156 was jailed in the aneurysm.This was subsequently removed.A 4.5 x 23 lvis device was placed through a headway 21 microcatheter.It was advanced and properly positioned for deployment with no issues.The distal end of stent opened without issues.Upon going around the curve the stent would not open.The stent was resheathed and another attempt was made.Same issue occurred at exactly the same spot in the curvature of the vessel.Stent was resheathed and removed from patient.A second lvis device was attempted.The microcatheter and stent were placed properly and deployment was attempted again.The stent was deploying distally but appeared not to be opening all the way.During second attempt, the components of the stent came apart.The stent was resheathed and removed.It appears the exposed guide caused a rupture of the second aneurysm.To control the bleeding an artery had to be permanently occluded, thus blocking blood flow to areas of the brain fed by this artery.The third attempt was made with an enterprise2.The stent would not open properly and was removed.The patients gcs post procedure was 4.The patient did not improve and subsequently died on (b)(6) 2016 after diagnosis of brain death.

• Brand Name: LVIS JR 2.5X23 (HDE)
• Common Device Name: LVIS JR.
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5948145
• Report Number: 2032493-2016-00217
• Device Sequence Number: 11163692
• Product Code: NJE
• UDI-Device Identifier: 00812636022215
• UDI-Public: (01)00812636022215(11)160602(17)190602(10)16060246
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: Physician
• Device Expiration Date: 06/01/2019
• Device Model Number: 213025-LVIS-D-HDE
• Device Lot Number: 16060246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• 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: 69 YR