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

Model Number FEM14080

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fem14080 endovascular stent graft allegedly experienced a difficulty to deploy and malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6)-year-old female whose weight was not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation confirmed difficult to deploy, however, unconfirmed malposition and entrapment of device.Further evaluation of the device, added a entrapment device code (1212).Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.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 indicated that model fem14080 endovascular stent graft allegedly experienced a difficulty to deploy and malposition of device.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 73-year-old female whose weight was 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: 9586366
• MDR Text Key: 177863773
• Report Number: 2020394-2020-00200
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008707
• UDI-Public: (01)04049519008707
• 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: 04/02/2020

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
• Device Operator: No Information
• Device Model Number: FEM14080
• Device Catalogue Number: FEM14080
• Device Lot Number: ANBY0431
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/02/2020
• Patient Sequence Number: 1