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

Model Number	FEM14040
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during a stent graft placement procedure for a stenosis with access through the a/v fistula, the stent graft allegedly failed to deploy.Reportedly, the device was removed without incident and another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft placement procedure for a stenosis with access through the a/v fistula, the stent graft allegedly failed to deploy.Reportedly, the device was removed without incident and another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.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 deployment system could only partially deploy the stent graft.One stent graft strut was found perforating the outer catheter surface which led to bloackage of the system and subsequent deployment failure.A process related issue could not be identified.Potential factors which may have caused or contributed to the reported issue have been considered.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risk.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.' regarding the anatomy of the placement site the ifu states: 'the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint has not been evaluated.', and '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: '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.'.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7375748
• Report Number: 2020394-2018-00291
• Device Sequence Number: 1710887
• Product Code: PFV
• UDI-Device Identifier: 04049519008684
• UDI-Public: (01)04049519008684
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2020
• Device Model Number: FEM14040
• Device Catalogue Number: FEM14040
• Device Lot Number: ANBX2682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 100