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

Model Number 212517-CAS-D-CN

Device Problem Component Missing (2306)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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.Only the delivery pusher and introducer were returned.The investigation found that the stent was not returned in the package; however, the record of the final packaging was pulled and all stents were verified before packaging the units.Therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that there was no stent found in the package.The stent was not seen under digital subtraction angiography (dsa) imaging, and no stent was found after the device was removed and pushed in the water.There was no patient involvement as the issue was noticed during prepping prior to use.The device was not used.

• Brand Name: LVIS D
• 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: 15718847
• MDR Text Key: 307587243
• Report Number: 2032493-2022-00426
• Device Sequence Number: 1
• Product Code: NJE
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 212517-CAS-D-CN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2020
• 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