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

Model Number MV-L553321

Device Problem Retraction Problem (1536)

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

Event Date 06/15/2023

Event Type  malfunction  

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.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported that during an mca aneurysm treatment, the stent was deployed from the m2 to m1, and the mesh was made thicker in the area where the aneurysm was large.After stent placement, the delivery wire was attempted to be removed by pulling it, but the distal tip of the delivery wire could not be retracted.Con-beam ct revealed no separation in the delivery wire.A microcatheter was advanced through the stent to retrieve the delivery wire tip inside the microcatheter.The delivery wire and microcatheter were both then removed from the patient.The procedure was successfully completed.The patient¿s condition was reported as ¿no health damage¿.

Manufacturer Narrative

The stent was implanted; therefore, it was not returned.The circumstances of the reported event could not be replicated for functional testing during the investigation.The pusher was returned.No visible damage was found on the returned pusher.The investigation found no damage or anomaly that could have contributed to the reported complaint.Without the return and physical evaluation of the implant, the investigation cannot determine if a condition exists that would have caused or contributed to the reported event.

• Brand Name: LVIS D
• Type of Device: 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: 17244331
• MDR Text Key: 318347499
• Report Number: 2032493-2023-00824
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041532
• UDI-Public: (01)04987892041532(11)210125(17)231231(10)210125565
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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 Expiration Date: 12/31/2023
• Device Model Number: MV-L553321
• Device Lot Number: 210125565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/01/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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