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

Model Number FEM08040

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The one device belonging to the sole complaint is expected to be 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 fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age was not provided.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The sample has been returned for evaluation.The investigation for the returned sample is confirmed for material perforation and partial deployment (misfire).Based on the available information, the root cause could not be determined.The device is labeled for single use.H10: g4 h11: h6 (device codes) 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 fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age was not provided.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The sample has been returned for evaluation.The evaluation identified the stent graft was partially deployed (misfire).Based on the available information, the root cause 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 indicated that model fem08040 endovascular stent graft allegedly experienced a misfire.This information was received from one source.The malfunction involved a patient with no reported consequence.The patient was reported as a male weighing 150 lbs; the patient's age 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: 9187837
• MDR Text Key: 162320094
• Report Number: 2020394-2019-03902
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,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: FEM08040
• Device Catalogue Number: FEM08040
• Device Lot Number: ANDR0784
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/31/2019; 03/31/2020
• Supplement Dates FDA Received: 01/07/2020; 04/02/2020
• Patient Sequence Number: 1