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

Model Number 214017-CAS-D-CN

Device Problem Retraction Problem (1536)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

As reported: when the stent was released, multiple attempts were made to push and pull the release, but the stent fell down.When retracting the stent, there was resistance, and the stent could not be retracted.The stent could not be retracted into the microcatheter.The stent and microcatheter removed together.Patient is normal.There was no patient injury nor intervention performed.

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

As reported: when the stent was released, multiple attempts were made to push and pull the release, but the stent fell down.When retracting the stent, there was resistance, and the stent could not be retracted.The stent could not be retracted into the microcatheter.The stent and microcatheter removed together.Patient is normal.There was no patient injury nor intervention performed.

Manufacturer Narrative

Items returned for investigation: 2x stent, 1x pusher, 2x microcatheter.Items not returned for investigation: 2x introducer, 1x pusher.Two stents and two microcatheters were returned for investigation and will be referred to as 1 and 2 for clarity.A single pusher was returned advanced inside of microcatheter 1.Stent 1 was returned fully deployed, and the measurements are not consistent with the size of the stent involved in the reported event; therefore, no further testing was conducted on stent 1.Stent 2 was returned detached in the hub of microcatheter 2.Pusher 1 was retrieved from microcatheter 1 and was found to have damage to the body coil and warning marks.Microcatheter 2 was found to be kinked at the distal end of the strain relief.Stent 2 was retrieved from microcatheter 2 and the measurements were consistent with the device involved in the reported complaint.The stent was loaded onto an in-house pusher with an in-house introducer and advanced into an in-house microcatheter.The stent was able to advance, resheathe, and deploy without resistance or premature detachment during the investigation.Two stents and two microcatheters were returned for investigation and were referred to as 1 and 2 during the investigation for clarity.Stent 1, pusher 1, and microcatheter 1 did not appear to have been involved in the reported event as this stent did not match the device size associated with the complaint.Stent 2, which did match the size of the reported device, was returned detached in the hub of microcatheter 2.Microcatheter 2 was found kinked at the distal end of the strain relief, which may have caused or contributed to the detachment of stent 2.As stent 2 was returned detached in the hub of microcatheter 2, this investigation could not determine if the device experienced issues retracting back into the microcatheter during the procedure, nor could the investigation determine whether the stent ¿fell down¿ as described in the reported event.Stent 2 was able to successfully advance through and retract into an in-house microcatheter without prematurely detaching during functional testing.The introducer and pusher associated with the reported stent was not returned for evaluation, so the investigation could not determine if they had caused or contributed to the reported complaint.

• 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: 19093928
• MDR Text Key: 340686339
• Report Number: 2032493-2024-00288
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429115923
• UDI-Public: (01)00842429115923(11)231006(17)260930(10)0000434333
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 214017-CAS-D-CN
• Device Lot Number: 0000434333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2023
• 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
• Treatment: HEADWAY 21 (LOT 0000464874, MODEL MC212150S-CN).