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

Model Number FEM12040

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore a lot history review is currently being performed.The device was returned for evaluation as well as medical images were provided for review.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 indicates that model fem12040 endovascular stent graft allegedly experienced detachment, entrapment and break.This report was received from one source.One patient was involved with no reported patient injury.The patients¿ age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was returned for evaluation as well as medical images were provided for review.The investigation is confirmed for break and detachment of the marker band.A definitive 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 malfunction.A review of the reported information indicates that model fem12040 endovascular stent graft allegedly experienced detachment, entrapment and break.This report was received from one source.One patient was involved with no reported patient injury.The 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: 10273076
• MDR Text Key: 198854484
• Report Number: 2020394-2020-04435
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: ANDQ3780
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1