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

Model Number 215533-CAS-D-CN

Device Problem Retraction Problem (1536)

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

Event Date 11/16/2023

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 stated to be available for return to the manufacturer, but it has not yet been returned.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 with the results.

Event Description

As reported, a stent was attempted to be retracted into the microcatheter for repositioning, but the stent could not be fully withdrawn.The microcatheter was removed with a small portion of the stent protruding from the tip of the catheter.There was no patient injury or intervention.

Manufacturer Narrative

Items returned for investigation: stent, pusher, introducer items not returned for investigation: microcatheter the stent was returned fully deployed and deformed at the distal end.The pusher was returned with the marker band detached from the body coil.The distal end of the stent was corrected by stretching the stent during the investigation.The stent was loaded onto an in-house pusher with an in-house introducer for the investigation testing as the returned pusher was stuck in the returned introducer due to residual blood throughout the introducer lumen.The stent was advanced into an in-house microcatheter and was able to be deployed, and resheathed without resistance during the investigation.The reported complaint is non-verifiable.The investigation of the returned stent system found the stent returned fully deployed with the distal end deformed, and the pusher marker band detached from the body coil.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.Per the event description, the stent could not be fully retracted back into the microcatheter, and a small portion of the stent protruded out of the microcatheter, which is consistent with the deformity observed on the distal end of the stent.However, as the stent was returned fully deployed and the microcatheter was not returned, the investigation could not verify the exact condition of the device described in the reported event, nor could the investigation determine when the stent deformity occurred (i.E., during the procedure, or during the return shipping).The stent deformity was able to be corrected during the investigation and the stent was able to successfully advance into an in-house microcatheter and deploy and resheathed without issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the stent deformity and pusher damage, but these conditions are consistent with the device experiencing forces over specification.

Event Description

As reported, a stent was attempted to be retracted into the microcatheter for repositioning, but the stent could not be fully withdrawn.The microcatheter was removed with a small portion of the stent protruding from the tip of the catheter.There was no patient injury or intervention.

• 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: 18370199
• MDR Text Key: 331050441
• Report Number: 2032493-2023-01137
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429116005
• UDI-Public: (01)00842429116005(11)220930(17)250831(10)0000263418
• 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: 02/20/2024

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
• Device Operator: Health Professional
• Device Model Number: 215533-CAS-D-CN
• Device Lot Number: 0000263418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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