MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRALUMINAL SUPPORT DEVICE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the devices part / lot number combination could not be performed as the lot and part numbers are unknown.The lvis stent was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided; however, operative notes were received and the investigation is ongoing.The alleged product issue could not be confirmed at this time.Upon completion of the investigation, a supplemental mdr report will be submitted.

Event Description

It was reported that a patient enrolled in the lvis pas study was admitted on september 13, 2016, for a re-coiling and stenting of a 3.5mm residual left posterior communicating artery (pcom) aneurysm.The aneurysm was secured with an lvis stent, stenting of the proximal coil, and distal carotid stenting.After the procedure, patient was reported to be neuro intact and following commands.A normal neuro examination was noted the morning of september 14, 2016.Approximately 2 hours later, the nurse noted expressive aphasia.Code stroke was initiated.Nihss was 3.A t-pa was started.Ctp suggested slow flow to the left hemisphere, but no dangerous ischemia noted.The patient was taken for invasive angiography, where widely patent vessels were noted throughout, and taken to the or for class a thrombectomy.On the morning of (b)(6) 2016, the patient was noted to be back at baseline with no symptoms of expressive or receptive aphasia, was able to follow all commands, and was able to accurately describe the events of yesterday.Results of a rue ultrasound showed the bruising to be superficial and not indicative of fistula or underlying vascular anomaly.78.6mg of alteplase administered intravenously was used to treat and reported to be resolved without sequelae and was also to be continued on asa/plavix.Diffusion restriction lesions were noted on the mri, which indicate an ischemic stroke rather than a tia.

Manufacturer Narrative

Investigation findings items returned: - n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.Complaint system review: a search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.Procedure note medical review: a detailed medical review of the operative report has been performed.Data review indicates that the patient received treatment for a 3.5 mm residual left pcom aneurysm on (b)(6) 2016.Aneurysm was secured with an lvis stent.On (b)(6) 2016, code stroke was initiated as the patient was noted expressive aphasia and the patient was unable to state his name, name objects, and did not appear to understand commands.Performance ctp suggested left hemisphere slow flow, but no dangerous ischemia noted.On (b)(6) 2016, axial ct of the brain without iv contrast, cta and ct perfusion of the brain performed with 40 ml isovue-370 iv contrast and axial ct angiogram of the neck were performed.Imaging results indicated asymmetrically decreased contrast opacification through the proximal (left petrous segment) ica stent concerning for stenosis or thrombus.There does appear to be opacification of the more distal cavernous and supraclinoid ica.Similarly, the more distal left ica/mca stent appears patent and concern for global hypoperfusion throughout the left cerebral hemisphere, possibly within the setting of decreased or absent flow through the left petrous ica stent and with collateral left mca supply via a-comm and p-comm.On (b)(6) 2016, the patient was taken for invasive angiography, and widely patent vessels noted throughout.On the morning of (b)(6) 2016 patient was noted to be back at baseline with no symptoms of expressive or receptive aphasia.Procedure note medical review conclusion: a detailed medical review of the post-operative report and discharge summary which contain operative procedure data was completed.Data review indicates that imaging results indicated asymmetrically decreased contrast opacification through the proximal (left petrous segment) ica stent concerning for stenosis or thrombus.Review of the operative report data does not provide any report of coil malfunction with premature detachment.In addition, the operative report upon medical review does not present data which indicates that the reported compliant is associated with the coil malfunction with detachment.A review of the post-operative report document findings section indicates coiling complicated by coil malfunction with premature detachment.Data review of this document does not indicate that the coil malfunction with detachment has an association with the adverse event (stroke) experience by the patient.Further, data review indicates that performance of a diagnostic angiogram indicates that a coil which extends from the coil mass into the petrous portion of the left internal carotid artery is again visualized and does not appear to move with the blood flow.Data review indicates that the two previously deployed stents are patent with excellent forward flow.Data reviewed indicates that there is no evidence of in stent stenosis or the presence of a clot.A coil that extends from the coil mass into the petrous portion of the left internal carotid artery is again visualized and does not appear to move with the blood flow.The patient was examined and determined to be back at baseline on (b)(6) 2016.Procedure note medical review conclusion: a detailed medical review of the discharge summary which contain operative procedure data was completed.Data review indicates that imaging results indicated asymmetrically decreased contrast opacification through the proximal (left petrous segment) ica stent concerning for stenosis or thrombus.The two previously deployed stents are patent with excellent forward flow.There is no evidence of in stent stenosis or the presence of a clot.A coil that extends from the coil mass into the petrous portion of the left internal carotid artery is again visualized and does not appear to move with the blood flow.The patient was examined and determined to be back at baseline on (b)(6) 2016.Investigation conclusion: without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.A detailed medical review of the discharge summary which contain operative procedure data was completed.Data review indicates that imaging results indicated asymmetrically decreased contrast opacification through the proximal (left petrous segment) ica stent concerning for stenosis or thrombus.The two previously deployed stents are patent with excellent forward flow.There is no evidence of in stent stenosis or the presence of a clot.A coil that extends from the coil mass into the petrous portion of the left internal carotid artery is again visualized and does not appear to move with the blood flow.The patient was examined and determined to be back at baseline on (b)(6) 2016.This report addresses the stent during the same procedure as the coil that unexpectedly detached reported under mfr report# 2032493-2023-00793.

Event Description

Please see section h10 for the investigation results.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 17122569
• MDR Text Key: 317203022
• Report Number: 2032493-2023-00792
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male