MAUDE Adverse Event Report: MICROVENTION, INC LVIS; INTRACRANIAL COIL-ASSISR STENT

Model Number 212525-CAS-D-CN

Device Problem Component Missing (2306)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that during treatment using a lvis device, no stent was observed under dsa imaging.It was reported that the device was used without inspection prior to use.There was no report of harm or injury to the patient.

Manufacturer Narrative

A search for non-conformances 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 not returned to the manufacturer for analysis.Therefore, the alleged product issue could not be confirm.If the device or additional information is received, microvention inc will issue a supplemental report.

Manufacturer Narrative

The reported complaint is nonverifiable as the stent was not returned and the physician did not provide any corroborating images.Per the ifu, the device should have been prepped by partially deploying in saline prior to insertion into the microcatheter.The investigation found no damage or anomaly to the pusher or introducer that would have contributed to the reported complaint.

• Brand Name: LVIS
• Type of Device: INTRACRANIAL COIL-ASSISR STENT
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15353642
• MDR Text Key: 305643123
• Report Number: 2032493-2022-00360
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020013
• UDI-Public: (01)00812636020013(11)210622(17)240531(10)210622584
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212525-CAS-D-CN
• Device Lot Number: 210622584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 55 KG