MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number	LEV3024-PMA
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.Imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.  .
Event or Problem Description
As reported: physician was doing an sac of an mca aneurysm with lvis evo.During lvis evo deployment, physician attempted to re-sheath device for repositioning and could not re-sheath device.Physician was able to bring up the sofia catheter for support and bring the headway 17 advanced microcatheter into the sofia where he was able to re-sheath the lvis evo.Physician completed case with a new lvis evo and a new headway 17 without incident.Patient is stable, no adverse events noted.
Event or Problem Description
As reported: physician was doing an sac of an mca aneurysm with lvis evo.During lvis evo deployment, physician attempted to re-sheath device for repositioning and could not re-sheath device.Physician was able to bring up the sofia catheter for support and bring the headway 17 advanced microcatheter into the sofia where he was able to re-sheath the lvis evo.Physician completed case with a new lvis evo and a new headway 17 without incident.Patient is stable, no adverse events noted.
Additional Manufacturer Narrative
Correction: model number in d4 was corrected.Items returned for investigation: stent, pusher, microcatheter items not returned for investigation: introducer the pusher was returned advanced into the microcatheter.The stent was advanced out of the microcatheter and fully retracted without resistance during the investigation.The pusher was retrieved from the microcatheter and was found to be bent at the body coil.Imaging review, md: three radiographic images are provided.They were taken of the monitor with a cell phone and are of medium quality.They are not labeled as to time or date.Image 1: ap oblique working projection single shot image with no contrast.A distal access catheter (dac) is positioned in the expected position of the distal cavernous ica.There is a micro catheter in the m1 middle cerebral artery and an lvis evo is beginning to be deployed.Image 2: ap oblique working projection (slightly different than image 1) with no contrast.Same as image 1, but the dac has been advanced to the expected position of the supraclinoid ica.Image 3: ap oblique working projection single shot image with no contrast.Same as image 2.These images do not explain why the stent could not be resheathed.The investigation of the returned stent system found that the stent did not experience resistance when advancing from or retracting into the returned microcatheter during functional testing.The pusher was found bent at the body coil after retrieval from the microcatheter; however, this did not contribute to resistance during the investigation.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: LVIS EVO
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19280685
• Report Number: 2032493-2024-00369
• Device Sequence Number: 12674767
• Product Code: QCA
• UDI-Device Identifier: 00842429117798
• UDI-Public: (01)00842429117798(11)231116(17)261031(10)0000458708
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LEV3024-PMA
• Device Lot Number: 0000458708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOFIA, HEADWAY 17.
• Patient Sex: Female