MAUDE Adverse Event Report: BARD LIFESTENT®; LIFESTENT VASCUALR STENT SYSTEM

Model Number	5F051703CS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon surgeon deploying stent, she noted a small piece of device separated from the implant delivery system on x-ray, surgeon inspected stent deploying device and didn't note anything unusual but seemed to think that it could be something from the stent device, she then had to deploy additional stents to trap the piece against the wall of artery.Bard rep was present and aware.

• Brand Name: LIFESTENT®
• Common Device Name: LIFESTENT VASCUALR STENT SYSTEM
• Manufacturer (Section D): BARD; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 9705846
• Report Number: 9705846
• Device Sequence Number: 3654980
• Product Code: NIP
• UDI-Device Identifier: 00801741120671
• UDI-Public: 00801741120671
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020
• Report Date (Section F): 01/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5F051703CS
• Device Catalogue Number: 5F051703CS
• Device Lot Number: ANDV1184
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/28/2020