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

Model Number FEM08100

Device Problems Positioning Failure (1158); Fracture (1260); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported information, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model fem08100 endovascular stent graft allegedly experienced failure to deploy, a fracture, and material perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient's age and weight were not provided.

Manufacturer Narrative

H10: for the reported information, the lot number was provided and a lot history review was performed.As a result of the investigation performed the complaint is confirmed for a positioning failure, fracture, and material perforation.A definite root cause for the reported event could not be determined.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 (1) malfunction.A review of the reported information indicated that model fem08100 endovascular stent graft allegedly experienced failure to deploy, a fracture, and material perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient's age and weight 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: 8783335
• MDR Text Key: 150848029
• Report Number: 2020394-2019-01480
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516
• 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: 10/09/2019

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
• Device Operator: No Information
• Device Model Number: FEM08100
• Device Catalogue Number: FEM08100
• Device Lot Number: ANCY4237
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/09/2019
• Patient Sequence Number: 1