MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM; STENTS DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	EX061003CS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
At some point during the use of a lifestent xl vascular and biliary stent in the femoral artery, an internal portion of the catheter came off and was retained in the pt's aorta.This was discovered on (b)(6) 2019 when pt was having an open aortic bi femoral bypass.A small plastic tube like structure was found by the surgeon in calcification and clot.This tube like structure was retained and examined.The structure is not radiopaque and unable to be seen under fluoroscopic examination or on ct.A similar lifestent xl 6 x 100 130 was examined and found to contain a similar tube like structure on the inner lumen of the stent guide.The surgeon was able to break off this inner lumen structure using significant force on the like catheter.

• Brand Name: LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: STENTS DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; tempe AZ 85281
• MDR Report Key: 8432743
• Report Number: MW5085000
• Device Sequence Number: 1795237
• Product Code: FGE
• UDI-Device Identifier: 04049519001272
• UDI-Public: (01)04049519001272
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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 Expiration Date: 01/13/2019
• Device Model Number: EX061003CS
• Device Catalogue Number: EX061003CS
• Device Lot Number: ANBN1467
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 105