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

Model Number MV-L352221

Device Problem Break (1069)

Patient Problem Aneurysm (1708)

Event Date 04/13/2022

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.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.It was stated that the device is available for evaluation, but it has not yet been returned to the manufacturer.The alleged issue could not yet be confirmed.If the device is received, an investigation will be performed and a supplemental mdr will be submitted.The two lvis stents that were implanted on (b)(6) 2022 , were reported under mfr.Report# 2032493-2022-00171.

Event Description

It was reported that 19 days post deployment of two lvis stents for the treatment of a ruptured aneurysm in the internal carotid artery, the aneurysm became slightly enlarged and the patient had to be retreated with an additional lvis blue stent.During removal of the delivery wire, however, it became caught in the area where the stent was implanted.The physician was able to remove the wire by raising the microcatheter and applying force.After detachment, the cone-beam ct revealed that the tip of the delivery wire had most likely broken off and remained in the patient.An additional lvis blue stent was implanted from c1 to c4 to affix the tip of the wire to the vessel wall.The procedure was successfully completed and the patient condition was reported as "non-serious health damage".

Manufacturer Narrative

The pusher was returned broken at the distal tip, which is consistent with the reported condition.Based on the information provided in the reported event, the distal end of the pusher may have gotten caught on one of the stents implanted during the procedure and become stuck.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the broken pusher, but the damage is consistent with the device experiencing forces over specification while the physician was attempting to remove the pusher during the procedure.

• 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: 14196513
• MDR Text Key: 290305265
• Report Number: 2032493-2022-00169
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041457
• UDI-Public: (01)04987892041457(11)210326(17)240229(10)21032656A
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/29/2024
• Device Model Number: MV-L352221
• Device Lot Number: 21032656A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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: HEADWAY21 PLUS.
• Patient Outcome(s): Required Intervention