MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X18 (HDE); STENT

Model Number	172516-LVISJ-C-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101)
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 instructions for use (ifu) identifies thrombus and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that treatment was performed on a wide-neck basilar artery aneurysm om (b)(6) 2017.Five coils were placed in the aneurysm, assisted by a balloon.All coils were implanted in the intended location.After placement of the coils, the lvis jr.Stent was successfully deployed and the procedure was completed.There was no reported difficulty deploying the stent.Sometime after the procedure, the patient was admitted to the hospital (admission date not provided) and imaging demonstrated in-stent thrombus.One week prior to the procedure, the patient's pru was 190.At that time, the patient was placed on a double dose of plavix.The pru on the day of the procedure was 191.The patient died on (b)(6) 2017.The pru was not checked on the date of the patient's death.The cause of the death is unknown.

• Brand Name: LVIS JR 3.5X18 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6752843
• Report Number: 2032493-2017-00183
• Device Sequence Number: 1371649
• Product Code: NJE
• UDI-Device Identifier: 00811425029893
• UDI-Public: (01)00811425029893(11)161104(17)191031(10)16110437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/28/2017

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: 172516-LVISJ-C-HDE
• Device Catalogue Number: 172516-LVISJ
• Device Lot Number: 16110437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/28/2017
• 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: 62 YR