MAUDE Adverse Event Report: MICROVENTION LVIS JR.; INTRALUMINAL DEVICES

Model Number 172010-CASJ-C-CN

Device Problem Break (1069)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that the stent had resistance during advancement in the catheter, and continued to push but the stent could not be advanced.When the stent was withdrawn, it was found that the stent separated from the pusher and the stent fell in the catheter.

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.Investigation conclusion the implant, pusher, and introducer were returned for evaluation; the associated microcatheter was not available for this investigation.The physical evaluation of the pusher found the distal marker band to be broken and the pusher's distal tip to be fractured with evidence of necking to the point of fracture; this indicates the device encountered tensile forces (i.E.Retraction) that exceeded the strength of the pusher material.No notable conditions were found with the returned implant.The implant was loaded onto a known, good, pusher and was successfully advanced through a lab-provided microcatheter.The microcatheter used during the procedure was not evaluated as part of this investigation, so it could not be determined if a condition existed that would have caused or contributed to the reported event.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19161349
• MDR Text Key: 341668078
• Report Number: 2032493-2024-00323
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103296
• UDI-Public: (01)00842429103296(11)210630(17)240531(10)21063052H
• 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: 04/22/2024

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: 05/31/2024
• Device Model Number: 172010-CASJ-C-CN
• Device Lot Number: 21063052H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 56 KG