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

Model Number MV-L553321

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/13/2024

Event Type  Injury  

Event Description

It was reported that the delivery wire broke.The flow diverter was implanted in another flow diverter that had already been implanted.When the delivery wire was withdrawn and removed, it was found that the delivery wire tip did not attach and may have been left in the va.There seemed to be no resistance.No additional treatment was performed.It was reported that the patient's condition is favorable, and no additional treatment is currently planned.

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for evaluation.However, a portion of the delivery system was stated to be available for return to the manufacturer for evaluation but has not yet been returned.Procedural or medical imaging was not provided.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.

Manufacturer Narrative

The physical device was received for evaluation along with two radiographic images.The images are not labeled as to date or time, or location of the vessel where the devices are, and they are of medium quality, as they were taken of a monitor with a cell phone.Picture 1 is an ap head unsubtracted radiograph, no contrast.A coil ball is seen in a medium-sized aneurysm, in the approximate location of the right pica.A fred stent is seen, spanning from proximal to distal to the aneurysm.The pusher wire is seen with its tip in the approximate mid to distal basilar artery.Picture 2 is a lateral head unsubtracted radiograph, no contrast: a coil ball is seen in a medium-sized aneurysm, in the approximate location of the right pica.A fred stent is seen, spanning from proximal to distal to the aneurysm.The pusher wire is seen with its tip in the approximate mid to distal basilar artery.These images do not explain why the problem occurred.Physical evaluation of the returned stent pusher verified the distal end to be broken with pitting near the fracture location.A review of the complaints database determined there to be no other similar complaints for this batch number at this time.A capa has been initiated to investigate pusher fractures.

Event Description

See h10.

• Brand Name: LVIS D
• 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
• MDR Report Key: 18682248
• MDR Text Key: 335071292
• Report Number: 2032493-2024-00118
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-L553321
• Device Lot Number: 0000209426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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