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

Model Number MV-L402821

Device Problems Retraction Problem (1536); Stretched (1601); Device-Device Incompatibility (2919); Unintended Movement (3026)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that an lvis d stent became displaced from its desired position during deployment in a vessel.It was attempted to retract the device inside of the microcatheter; 50% of the stent had been deployed at that point.The stent could not be completely withdrawn into the microcatheter and the microcatheter was withdrawn with a portion of the stent protruding from the distal end of the catheter.The stent was also stretched a little.The stent was prepared again and advanced to the treatment site, but encountered heavy resistance and was withdrawn.The procedure was successfully completed using another stent.The patient's condition was described as "no health damage.".

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 discarded at the user facility and not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12754522
• MDR Text Key: 284371706
• Report Number: 2032493-2021-00431
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 04987892063176
• UDI-Public: (01)04987892063176(11)210216(17)240131(10)21021658W
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: MV-L402821
• Device Lot Number: 21021658W
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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