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

Model Number	172014-LVISJ-C-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101); Weakness (2145)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
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 remains 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 development of thrombus was not related to the stent, but was solely the result of the failure of the patient to maintain post-procedure anti-platelet therapy.The ifu identifies neurologic insufficiencies including stroke as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that treatment was performed on a recurrent left a2/a3 pericallosal/callosomarginal aneurysm that had been previously coiled.The patient had been pre-operatively treated with brilinta, as he was a non-responder to plavix.The lvis jr.Was implanted at the neck of the aneurysm and then the aneurysm was subsequently coiled, without issues.The patient was discharged on post-op day 1 on aspirin and brilinta.On post-op day 3, the patient returned with right leg weakness with associated numbness.The patient had not taken his aspirin or brilinta the day before.Mri showed embolic strokes in the left aca territory.Angiography demonstrated a small amount of thrombus in the distal aspect of the stent.Antiplatelet therapy was resumed and the patient was also placed on a heparin drip for 3 days while under observation in the hospital.Repeat angiography demonstrated resolution of the thrombus, and the patient was discharged.One month later, the patient was seen in clinic and noted to be doing better with a minor amount of residual right leg weakness.Mri performed 6 months after the procedure showed no recurrent aneurysm and no sign of in-stent stenosis or occlusion.The physician stated that the event was not related to the stent, but rather to the patient skipping anti-platelet therapies.

• Brand Name: LVIS JR 2.5X17 (HDE)
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6626900
• Report Number: 2032493-2017-00136
• Device Sequence Number: 556021
• Product Code: NJE
• UDI-Device Identifier: 00812636020136
• UDI-Public: (01)00812636020136(11)151008(17)181008(10)15100834
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2017

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: 10/08/2018
• Device Model Number: 172014-LVISJ-C-HDE
• Device Lot Number: 15100834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/08/2017
• 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: Required Intervention
• Patient Age: 60 YR