MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 4.0X22; INTRALUMINAL SUPPORT DEVICE

Model Number MV-L402221

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

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 not returned to the manufacturer for investigation.The root cause of the complaint cannot be determined.

Event Description

It was reported that after the stent had been deployed approximately 50% at the intended treatment site, the microcatheter slid down and the stent was pulled out of position.An attempt was made to resheath the stent, but it could not be withdrawn back into the microcatheter due to high resistance.The stent was removed from the patient without incident and another stent was used to successfully complete the procedure.There was no reported patient injury or additional intervention.

• Brand Name: LVIS 4.0X22
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10041032
• MDR Text Key: 191739491
• Report Number: 2032493-2020-00120
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892063152
• UDI-Public: (01)04987892063152(11)191021(17)220930(10)19102153X
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2020

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: 09/30/2022
• Device Model Number: MV-L402221
• Device Lot Number: 19102153X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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