MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL DEVICES

Model Number LEV2522-MVE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device is reported available but has not been returned to the manufacturer for analysis.Therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.

Event Description

It was reported that during treatment of a patient enrolled in the selant study, an lvis evo was used for a stent assisted coiling case.It was observed that following successful deployment of the stent and subsequent withdrawal of the delivery wire, the radio-opaque tip detached from the delivery wire.A follow up post procedure x-ray and mr confirmed there were no clinical issues.Additional information indicated the radio-opaque tip remained within the stent.No intervention was taken to remove the tip.The patient was reported to be well and discharged from the hospital.No additional treatment was planned.

Manufacturer Narrative

Items returned for investigation: pusher, microcatheter.Items not returned for investigation: stent, introducer.The pusher was returned broken at the distal tip.The microcatheter was wavy at 50cm from the distal tip.The pusher distal tip was examined under high magnification confirming that the tip was broken.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL DEVICES
• 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: 17012249
• MDR Text Key: 316417122
• Report Number: 2032493-2023-00749
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103449
• UDI-Public: (01)00842429103449(11)230303(17)260228(10)0000327229
• 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: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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
• Device Operator: Health Professional
• Device Model Number: LEV2522-MVE
• Device Lot Number: 0000327229
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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): Other