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

Model Number 213522-CAS-D-CN

Device Problem Retraction Problem (1536)

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

Event Date 12/24/2023

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance's 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, and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported that the procedure was a stent assisted coil embolization, with the location of the aneurysm close to the tip of the basilar artery, and the length and width of the aneurysm was approximately 1mm.The parent vessel was on the basilar artery; the vessel was reported to be normal, without calcification or tortuosity, and the vessel diameter was between 2.2mm to 2.60mm.During the attempt to release the stent, the pusher wire was blocked, and the second half of the stent could not be released.After the stent was removed, found the pusher wire was stuck on the wall of the stent.The same type of stent was used; the release was normal, and the procedure was successfully completed.The patient was reported to be doing fine.

Manufacturer Narrative

Investigation conclusion: the stent was returned fully deployed and unattached to the pusher.The stent was returned deformed at the proximal end and the pusher was returned broken, which are consistent with difficulty retracting/re-sheathing the device.However, the circumstances of the damage could not be determined from the investigation.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 18568030
• MDR Text Key: 333540110
• Report Number: 2032493-2024-00070
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429115909
• UDI-Public: (01)00842429115909(11)231026(17)260930(10)0000446974
• 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: 03/01/2024

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: 213522-CAS-D-CN
• Device Lot Number: 0000446974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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 MICROCATHETER.; HEADWAY DUO.
• Patient Age: 56 YR
• Patient Sex: Male