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

Model Number FEM14120

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 malfunction.A review of the reported information indicated that model fem14120 endovascular stent graft allegedly experienced partial deployment.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient age, gender, and weight were not reported.

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 investigation is confirmed for partial deployment and material perforation.Based upon the available information, the 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 fem14120 endovascular stent graft allegedly experienced partial deployment and material perforation.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient age, gender, and weight were not reported.

• 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: 9188763
• MDR Text Key: 162363261
• Report Number: 2020394-2019-03919
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008721
• UDI-Public: (01)04049519008721
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FEM14120
• Device Catalogue Number: FEM14120
• Device Lot Number: ANDS1235
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1