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

Model Number MV-L401721

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/06/2021

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 device was implanted in the patient and not returned for evaluation.Procedural or post-procedural medical imaging was not provided.The event as described could not be confirmed.

Event Description

It was reported that during treatment of a c3 aneurysm, an lvis stent was implanted without issues.However, poor blood flow was detected and in-stent thrombosis was suspected to be the cause.Prasugrel was administered and the patient was observed to be stable.The patient's condition was reported to be "not serious," and "recovered.".

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 implanted in the patient and not returned for evaluation.Procedural or post-procedural medical imaging was not provided.The event as described could not be confirmed.

Event Description

It was reported that during treatment of a c3 aneurysm, an lvis stent was implanted without issues.However, poor blood flow was detected and in-stent thrombosis was suspected to be the cause.Prasugrel was administered and the patient was observed to be stable.The patient's condition was reported to be "not serious," and "recovered.".

• 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: 13172859
• MDR Text Key: 285238252
• Report Number: 2032493-2022-00007
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 04987892063138
• UDI-Public: (01)04987892063138(11)191111(17)221031(10)191111559
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: MV-L401721
• Device Lot Number: 191111559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG