MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM12060

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the device entrapment.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model fem12060 endovascular stent graft allegedly entrapment of device.The information was received from a single source.This malfunction involved one patient with no patient consequences.Patients' age, weight and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the device entrapment, positioning failure and material perforation.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: b5, g4.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model fem12060 endovascular stent graft allegedly entrapment of device, material perforation and positioning failure.The information was received from a single source.This malfunction involved one patient with no patient consequences.Patients' age, weight and gender were not provided.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10731504
• MDR Text Key: 212984069
• Report Number: 2020394-2020-06039
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: No Information
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANDR0774
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/13/2021
• Patient Sequence Number: 1