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

Model Number 172524-CASJ-C-CN

Device Problem Break (1069)

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

Event Date 07/23/2023

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 and medical imaging were returned to the manufacturer for analysis and the investigation is currently underway.Upon completion of the investigation, a supplemental report will be submitted.

Event Description

It was reported that after the stent was completely released, the physician attempted to retrieve the delivery wire of the stent and found that the head end of the delivery wire was broken in the blood vessel.An immediate angiography revealed that the broken part was attached to the blood vessel wall and did not float into the vessel.The patient was reported to be stable and did not require second treatment.

Manufacturer Narrative

Only the pusher was returned for evaluation.The investigation of the returned pusher found the distal end to be damaged and broken with a chipped section at 9.0cm from the proximal marker band.The pusher was sent to a third-party metallurgical expert for scanning electron microscopy and energy dispersive analysis of the observed break condition.The analysis suggests the unit broke due to a mechanical failure, which is consistent with the device experiencing forces over-specification.Secondarily, pitting/corrosion was observed on the pusher and was determined to have occurred after removal from the patient.The corrosion noted on the pusher is likely a result of disinfection, cleaning, and/or storage of the device after removal from the patient.The review of the provided medical imaging could not verify if the alleged pusher fragment separated and remained within the patient as described in the reported event; therefore, the full reported event could not be verified based on the known information.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17561371
• MDR Text Key: 321678343
• Report Number: 2032493-2023-00908
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103340
• UDI-Public: (01)00842429103340(11)220901(17)250831(10)0000248925
• 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: 07/25/2023

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 Model Number: 172524-CASJ-C-CN
• Device Lot Number: 0000248925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: 69 YR
• Patient Sex: Female