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

Model Number 172010-CASJ-C-CN

Device Problem Retraction Problem (1536)

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

Event Date 02/10/2022

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 stated to be available for evaluation but has not yet been returned.If the device is received the investigation will be performed and a supplemental report will be submitted.The instructions for use ifu identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during treatment of an anterior communicating aneurysm, the stent was partially deployed however, could not be retrieved for additional adjustment.The stent and the microcatheter were removed together successfully.The patient was reported to be fine.

Manufacturer Narrative

The reported complaint is unconfirmed.The investigation of the returned stent system found the stent returned retrieved into the introducer.The device was able to successfully advance through the returned introducer and through an in-house microcatheter and be retracted back into the microcatheter and introducer during functional testing.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: LVIS JR.
• 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: 15180371
• MDR Text Key: 305066758
• Report Number: 2032493-2022-00312
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103296
• UDI-Public: (01)00842429103296(11)200902(17)230831(10)20090251Y
• 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,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 172010-CASJ-C-CN
• Device Lot Number: 20090251Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 57 KG