MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 4.5X32X28; STENT

Model Number MV-L453221

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

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 review.Therefore, an investigation could not be conducted.

Event Description

It was reported that attempts to withdraw the lvis stent within the introducer were unsuccessful the stent was removed from the patient in its entirety along with the microcatheter.There was no reported patient injury or intervention.

• Brand Name: LVIS 4.5X32X28
• Type of Device: STENT
• 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: 9209959
• MDR Text Key: 188869080
• Report Number: 2032493-2019-00242
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041495
• UDI-Public: (01)04987892041495(11)181211(17)211130(10)18121153K
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: D324109
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: MV-L453221
• Device Lot Number: 18121153K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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: 55 YR