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

Model Number	LEV3517-PMA
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for analysis.However, the device has not been returned for analysis.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that during preparation, the stent implant was not present on the tip of the delivery pusher.There was no interaction between the device and the patient; another stent of the same size was selected and implanted.The patient was reported to be "good.".
Additional Manufacturer Narrative
Items returned for investigation: pusher, introducer.Items not returned for investigation: stent.The pusher was returned in the introducer.No stent was returned.No damage to the pusher or introducer was found.The product pouch was returned open.Per the pre-packaging inspection, the stent implant is to be retracted into the introducer until the distance from distal end of pusher to distal tip of the introducer is minimum 5 mm.The device is then inserted into the dispenser coil and the molded cap is then placed at the proximal end of the pusher to secure the device in place.The build record associated with the lvis evo lot number 0000475479 indicates that all units in this lot passed this inspection step; therefore, the stent would have been present inside the introducer prior to the final packaging of the device.The investigation found the product pouch was returned open.The stent was not returned with the pusher and introducer for evaluation.The event description indicates that the stent was missing at the time of device preparation; however, per the build record associated with the lvis evo lot number 0000475479, all units within the lot passed the pre-packaging inspection, indicating that the stent was present within the introducer when the device was inserted into the dispenser coil prior to the final packaging.As the product pouch was returned open, this investigation could not examine the device in the exact condition it was in out-of-box to further assess the alleged product issue.
Event or Problem Description
It was reported that during preparation, the stent implant was not present on the tip of the delivery pusher.There was no interaction between the device and the patient; another stent of the same size was selected and implanted.The patient was reported to be "good.".

• 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: 19767829
• Report Number: 2032493-2024-00548
• Device Sequence Number: 18337479
• Product Code: QCA
• UDI-Device Identifier: 00842429117828
• UDI-Public: 00842429117828
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: LEV3517-PMA
• Device Catalogue Number: LEV3517
• Device Lot Number: 0000475479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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
• Patient Sex: Unknown