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

Model Number 212525-CAS-D-CN

Device Problem Premature Separation (4045)

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

Event Date 08/23/2021

Event Type  Injury  

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 complaint is non-verifiable as the stent was returned too damaged to be loaded for further investigation.The stent was returned separated from the pusher, but the physical evaluation could not determine when or where the stent separated.However, the inability to push the stent is consistent with the damage to the pusher.The damage to the stent is consistent with overload in force when retrieving the stent during the procedure.

Event Description

It was reported that during treatment of an aneurysm, the front of an lvis d stent was deploying well in the parent artery when it would no longer advance.The microcatheter was removed and it was observed that the stent had detached prematurely.A portion of the device was protruding from the tip of the microcatheter.There was no patient injury or intervention.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12841280
• MDR Text Key: 285956729
• Report Number: 2032493-2021-00452
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00812636020013
• UDI-Public: (01)00812636020013(11)201117(17)231031(10)201117566
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 212525-CAS-D-CN
• Device Lot Number: 201117566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 76 KG