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

Model Number	FEM14100
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the stent graft allegedly deployed about 3-5% and then would not deploy any further in a slightly tortuous mid-forearm lesion.The delivery system was removed without incident.Reportedly, another stent graft was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that the stent graft allegedly deployed about 3-5% and then would not deploy any further in a slightly tortuous mid-forearm lesion.The delivery system was removed without incident.Reportedly, another stent graft was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.Based on the investigation of the returned catheter sample it was confirmed that the delivery system could only partially deploy the stent graft.Delivery system elongation over the entire length indicated that excessive release force was present when the user unsuccessfully tried to deploy the stent graft.An indication for a process related issue could not be found.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.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: '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.' (b)(4).

• 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: 8016406
• Report Number: 2020394-2018-01948
• Device Sequence Number: 16502561
• Product Code: PFV
• UDI-Device Identifier: 04049519008714
• UDI-Public: (01)04049519008714
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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 Model Number: FEM14100
• Device Catalogue Number: FEM14100
• Device Lot Number: ANBZ2043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 59