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

Model Number 172020-CASJ-C

Device Problem Retraction Problem (1536)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 loaded onto the returned pusher and was able to be advanced and retracted in a new microcatheter without issue.

Event Description

It was reported that an lvis jr stent was to be implanted to treat an aneurysm of the middle cerebral artery trifurcation, but it would not open.The stent could not be completely retracted into the microcatheter.The physician removed the microcatheter with a portion of the stent still outside of it.There was no reported patient injury or intervention.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrance callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11683304
• MDR Text Key: 249115548
• Report Number: 2032493-2021-00141
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019111
• UDI-Public: (01)00810170019111(11)201102(17)231031(10)201102594
• 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: 04/18/2021

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 Expiration Date: 10/31/2023
• Device Model Number: 172020-CASJ-C
• Device Lot Number: 201102594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• 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
• Patient Age: 44 YR
• Patient Weight: 54