MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 5.5X33X29; INTRALUMINAL SUPPORT DEVICE,

Model Number MV-L553321

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance associated with the part/lot number combination of the device could not be conducted as the lot number was not provided.The device was returned to the manufacturer for evaluation.The investigation in currently underway.The instructions for use identifies premature detachment as a potential complication associated with use of the device.

Event Description

It was reported that after half of the stent had been deployed, the stent detached from the delivery wire in the microcatheter.A gooseneck snare was advanced through the microcatheter, the stent was grabbed with the snare, and the stent and snare were removed through the guide catheter.There was no reported patient injury.

Manufacturer Narrative

The stent was returned separated from the pusher.The stent did not appear to be damaged.The stent was reloaded onto the pusher and was able to be advanced into the microcatheter.The stent did not have issues deploying.The reported complaint is unconfirmed, as the stent did not have issues opening and tracking within the microcatheter.The stent did not detach prematurely during testing.The root cause of this complaint cannot be determined.

• Brand Name: LVIS 5.5X33X29
• Type of Device: INTRALUMINAL SUPPORT DEVICE,
• Manufacturer (Section D): MICROVENTION, INC.; 13 enterprise; aliso viejo, ca
• MDR Report Key: 10287193
• MDR Text Key: 203831340
• Report Number: 2032493-2020-00165
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041532
• UDI-Public: (01)04987892041532(11)180911(17)210831(10)180911523
• 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,Followup
• Report Date: 06/18/2020

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: 08/31/2021
• Device Model Number: MV-L553321
• Device Lot Number: 180911523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1