MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X28 (HDE); LVIS JR.

Model Number	172530-LVISJ-C-HDE
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	05/20/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The lvis jr.Device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases.Per the instructions for use; potential complications include, but are not limited to: use of the lvis jr.Device is contraindicated under these circumstances: patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated/ patients with known hypersensitivity to nickel-titanium/ patients with anatomy that does not permit passage or deployment/ possible complications include but are not limited to the following: bleeding or hemorrhage including intracerebral, retroperitoneal or other locations/ complications of arterial puncture including pain, local bleeding (hematoma) or injury to the artery or adjacent nerves/device migration, distal embolization, headache, incomplete aneurysm occlusion, neurologic deficits including stroke and/or death, perforation or dissection of the vessel(s), pseudoaneurysm formation, rupture or perforation of aneurysm, transient ischemic attack (tia) or ischemic stroke, vasospasm, vessel occlusion, vessel stenosis or thrombosis.Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it remains within the patient.No device malfunction was reported, however adverse event occured during the procedure.(b)(4).
Event or Problem Description
The patient was reported to be an (b)(6) female with a history of intermittent vision changes suggestive of posterior circulation tia.Imaging revealed an approximately 9.7 x 6.2 x 6.9 mm saccular aneurysm arises superiorly from the p1 segment of the right posterior cerebral artery.There is a wide neck to the aneurysm measuring 6.4 mm in diameter.On 5/20/2016- reported treatment description: following access, the patient demonstrated with an approximately 6x10 mm sized broad-based right p1 segment aneurysm.An unsuccessful attempt was made to introduce the 7 mm coil.However, this was not successful due to the broad neck of the aneurysm.Subsequently it was decided to place the stent across the aneurysm.The stent was successfully deployed.Post stenting angiogram does not demonstrate any complication.Four embolization coils were placed successfully.Multiple control angiograms were performed.There are no thromboembolic complications.The final angiogram demonstrates no thromboembolic complications.The guiding catheter was removed.The patient was successfully extubated.The immediate neuro examination does not demonstrate any new neurological deficits.The patient was transferred to the icu in stable condition.Status post embolization of right posterior cerebral artery aneurysm with associated artifact which limits evaluation to some degree.No evidence of intracranial hemorrhage.Possible new decreased attenuation in the right cerebellar hemisphere could indicate an infarct.Images are degrade by motion artifact.Multiple small to moderate-sized patchy areas of restricted diffusion in the right cerebellum, bilateral occipital lobes and left inferior temporal lobe consistent with acute infarcts.Small-sized bilateral acute thalamic infarcts.On 5/21/2016- reported treatment description: following access, an angiogram was performed.It demonstrates minimal amount of non-flow-limiting thrombus in the stent.The distal blood flow appear normal.There is no evidence of large vessel occlusion.Subsequently intravenous integrilin infusion was started.Multiple left vertebral angiograms were performed.There is no evidence of progression of thrombus.There is minimal improvement in extent of thrombus.Subsequently the right femoral sheath was most sutured in place.There is minimal thrombus in the previously placed left p1 segment- basilar artery stent.15 mg of integrilin was administered as a bolus dose.Continuous intravenous integrilin infusion was also started.On day following procedure, the patient experienced a thalamic stroke.Patient expired (b)(6) 2016.Coils used: microvention terumo hydroframe 10 7mm x 28cm lot #160404f1.Microvention terumo lvis jr intraluminal support 3.5mm x 28mm lot # 16032231.Microvention terumo microplex 10 5mm x 15cm lot #150901v2 (x 2).Microvention terumo microplex platinum vfc 3-6mm x 15cm lot #150901lc1 (x 2).

• Brand Name: LVIS JR 3.5X28 (HDE)
• Common Device Name: LVIS JR.
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5748744
• Report Number: 2032493-2016-00144
• Device Sequence Number: 13457115
• Product Code: NJE
• UDI-Device Identifier: 00811425029916
• UDI-Public: (01)00811425029916(11)160322(17)190322(10)16032231
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: H130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2016

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?: No
• Operator of Device: Physician
• Device Model Number: 172530-LVISJ-C-HDE
• Device Lot Number: 16032231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Initial Report FDA Received Date: 06/24/2016
• 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; Other
• Patient Age: 86 YR