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

Model Number FEM12040

Device Problems Material Perforation (2205); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was not returned to bd for evaluation.Therefore, the investigation of the reported material perforation and misfire is inconclusive.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 malfunction indicated that model fem12040 endovascular stent graft allegedly experienced material perforation and misfired.This report was received from one source.This malfunction involved a patient with no patient consequences.Age, weight, and gender for the patient was not provided.

Manufacturer Narrative

For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was not returned to bd for evaluation.Therefore, the investigation of the reported material perforation and misfire is inconclusive.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 (1) malfunction.A review of the reported malfunction indicated that model fem12040 endovascular stent graft allegedly experienced material perforation and misfired.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a 58 year-old male weighing 175 lb.

• 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: 9587433
• MDR Text Key: 180123672
• Report Number: 2020394-2020-00227
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639
• 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: 04/03/2020

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: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANDR3727
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/03/2020
• Patient Sequence Number: 1