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

Model Number 172014-CASJ-C-CN

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/16/2023

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is currently ongoing.A supplemental report will be submitted with the findings and conclusions.

Event Description

It was reported that during insertion into a microcatheter, a stent encountered resistance.After removal, it was noticed that the tip of the stent's delivery system had become detached.It was removed from the patient.There was no injury or intervention.

Event Description

It was reported that during insertion into a microcatheter, a stent encountered resistance.After removal, it was noticed that the tip of the stent's delivery system had become detached.It was removed from the patient.There was no injury or intervention.

Manufacturer Narrative

The reported complaint is unconfirmed as the pusher was returned intact and the stent was able to advance into a new microcatheter without resistance during the investigation.The stent was also returned undamaged.The investigation found no damage or anomaly that could have contributed to the reported complaint.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17182710
• MDR Text Key: 317919320
• Report Number: 2032493-2023-00808
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103302
• UDI-Public: (01)00842429103302(11)210422(17)240331(10)21042258G
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/05/2023

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: 03/31/2024
• Device Model Number: 172014-CASJ-C-CN
• Device Lot Number: 21042258G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 59 KG