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)
Date of Event	05/25/2017
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 vessel dissection was not related to the stent, and that nothing different could have been done.The instructions for use (ifu) identifies hemorrhage and death as potential complications associated with use of the device.The device was used during the same procedure as was reported in mfr.Report# 2032493-2017-00152.
Event or Problem Description
It was reported that a stent-assisted coiling treatment was performed on an anterior communication artery (a-comm) aneurysm via the right internal carotid artery, on a patient with 4-5 aneurysms in the intracranial vasculature.The microcatheter was placed across the a1 to the contralateral a2, and the stent was advanced through the microcatheter then deployed.The stent looked well apposed.The microcatheter was re-crossed through the deployed stent to attempt an exchange for a smaller microcatheter in order to access one of the cells.A few minutes later, a severe bleed was discovered with roadmap imaging; however, the source of the bleed could not be determined.Protamine was administered to the patient and a temporary coil was placed in the right a1 to stop the bleeding.Once the bleeding stopped, the previous angiograms were reviewed.The images revealed the bleeding was present prior to the stent implantation and the tortuous a2 to the a-comm to the contralateral a2 vessel segment was straightened out by the microcatheter.Surgical intervention was performed to relieve intracranial pressure and evacuate clot.It was the consensus of two physicians that there was a spontaneous/spiral dissection that resulted from the straightening out of the vessel during access by the microcatheter and the stent tracking through it.Four (4) days after the procedure, the patient died.The physician stated the cause of death was hemorrhage from the vessel dissection caused by straightening of the vessel when the microcatheter crossed the target area.The physician also stated the stent was not "to blame" and nothing different could have been done.

• Brand Name: LVIS JR 2.5X17 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6665726
• Report Number: 2032493-2017-00151
• Device Sequence Number: 10781201
• Product Code: NJE
• UDI-Device Identifier: 00812636020136
• UDI-Public: (01)00812636020136(11)160215(17)190215(10)16021527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/25/2017

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: 02/15/2019
• Device Model Number: 172014-LVISJ-C-HDE
• Device Lot Number: 16021527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/23/2017
• 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