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

Model Number 213015-CAS-D-CN

Device Problem Activation Failure (3270)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 returned to the manufacturer for evaluation.The investigation is currently underway.

Event Description

It was reported that a lvis d stent could not be fully retracted into the microcatheter.The stent and microcatheter were removed together from the patient.There was no reported patient injury or intervention.

Manufacturer Narrative

The reported complaint is unconfirmed as the stent was able to be resheathed into the introducer and retrieved into the microcatheter during the investigation.The pusher was found to be damaged at the distal tip and the pusher wire.The damage did not affect the function of the device during lab testing; the damage is consistent with overload in force in attempting to retrieve the stent during the procedure.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11721176
• MDR Text Key: 249192182
• Report Number: 2032493-2021-00152
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020020
• UDI-Public: (01)00812636020020(11)200330(17)230228(10)20033056H
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 213015-CAS-D-CN
• Device Lot Number: 20033056H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70