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

Model Number 172020-CASJ-C-CN

Device Problem Break (1069)

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

Event Date 10/23/2023

Event Type  Injury  

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 implanted.However, the pusher was returned and imaging was provided for investigation to the manufacturer.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

As reported, when the stent was completely released and the pusher was retracted, found that the marker at the head of the pusher had broken inside the blood vessel, and at this time, the broken object could no longer be removed.Immediate imaging did not reveal any head end dissociation within the parent vessel.The flow diverter was semi-released, assist the coils filling (not mv¿s coils).After the coils filled and flow diverter released completely, it was found that the distal end of the guide wire was broken in the vessel when retreating the guide wire.Immediate imaging find that the broken guide wire tip did not float in patient¿s vessel.The patient is in stable condition.

Manufacturer Narrative

Initially, a single radiographic image was provided for this investigation.The image is a single-shot cropped radiograph of the base of the skull in lateral projection, no contrast.An lvis stent is seen in a vessel, which the investigation is unable to identify as it is not specified in the event description and no contrast was injected in the provided image.The stent has a vertical and a horizontal portion, and coils are seen in a small aneurysm at the genu of the stent.A radiopaque short wire (presumably the broken pusher wire described in the event) is seen with its base at the distal stent, extending outside the stent distally.This image does not explain why the pusher wire broke.Following the initial review of the provided image, the pusher was returned within the microcatheter.Analysis of the pusher verified the distal end to be fractured with pitting and a ¿cup¿ break profile indicating tensile forces exceeded the strength of the metal at that location.A review of the complaints database determined there to be no other complaints for this batch number at this time.A capa has been initiated to investigate pusher fractures.

Event Description

No additional information provided.

• Brand Name: LVIS JR.
• 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: 18262659
• MDR Text Key: 329667924
• Report Number: 2032493-2023-01089
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103319
• UDI-Public: (01)00842429103319(11)220323(17)250228(10)0000169590
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 172020-CASJ-C-CN
• Device Lot Number: 0000169590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG