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

Model Number FEM08100

Device Problems Fracture (1260); Difficult to Remove (1528); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during a stent graft placement procedure to declot the avf using a bareback approach, the stent graft allegedly partially deployed and the shaft allegedly broke.It was further reported that the stent graft was removed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the user could not fully deploy the stent graft inside patient and that the outer sheath fractured during the attempt to deploy the stent graft.The outer sheath was found elongated near the fracture site, which indicates that a increased deployment force was encountered.Increased friction was considered as reason for increased deployment force and subsequent catheter fracture.An indication for a manufacturing related issue could not be found.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the ifu states: 'the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure' furthermore, the ifu states: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' under 'materials required' the ifu states 'introducer sheath with appropriate inner diameter'.

Event Description

It was reported that during a stent graft placement procedure to declot the av fistula in the upper arm through the basilic vein, using a bareback approach, the stent graft allegedly partially deployed and the shaft allegedly broke as excessive force was necessary in an effort to deploy the stent graft.It was further reported that the delivery system was removed with alleged difficulty since the shaft had broken.Reportedly, another delivery system was used to complete the procedure.There was no reported patient injury.

• 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: 8026116
• MDR Text Key: 125771289
• Report Number: 2020394-2018-01961
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

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: Health Professional
• Device Model Number: FEM08100
• Device Catalogue Number: FEM08100
• Device Lot Number: ANBY0422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 62