MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X17 MM; INTRALUMINAL SUPPORT DEVICE

Model Number 172014-CASJ-C

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

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 stent, pusher, introducer, and microcatheter were returned for evaluation.Upon initial investigation, there did not appear to be any damage to the stent.The stent was reloaded back into the introducer.The stent was able to be resheathed and deployed through the microcatheter without any friction.The reported complaint is unconfirmed, as the stent was able to be resheathed and then deployed without any issues.The conditions of use cannot be recreated in the laboratory setting; however, it is possible that tortuous anatomy may have prevented the stent from resheathing during the procedure.

Event Description

It was reported that stent-assisted embolization treatment was performed on an anterior communicating artery aneurysm.During stent deployment in the a2 artery segment, an attempt was made to resheath the stent for repositioning; however, the stent could not be completely resheathed.The partially resheathed lvis jr.Was removed together with the microcatheter without incident.There was no reported patient injury.The patient did "fine" post-procedure and was discharged after a few days of observation.

• Brand Name: LVIS JR 2.5X17 MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9434591
• MDR Text Key: 188869532
• Report Number: 2032493-2019-00281
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019104
• UDI-Public: (01)00810170019104(11)180807(17)210731(10)18080752N
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 172014-CASJ-C
• Device Lot Number: 18080752N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 62