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

Model Number	FEM10100
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
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 is currently under way.
Event or Problem Description
It was reported that during a stent graft deployment procedure of the brachial vein via forearm graft access site, the stent graft allegedly failed to deploy.It was further reported that the procedure was completed with another device.There was no reported patient injury.
Additional 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: a stent graft delivery system was returned.Based on the investigation of the returned sample it was confirmed that the delivery system could only partially deploy the stent graft.The outer sheath was found elongated in the proximal section indicating that high friction was present during the deployment attempt.No indication could be found for a manufacturing related issue.As a result of the investigation performed the reported issue was confirmed.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.'.
Event or Problem Description
It was reported that during a stent graft deployment procedure of the brachial vein via forearm graft access site, the stent graft allegedly failed to deploy.It was further reported that the procedure was completed with another device.There was no reported patient injury.

• Brand Name: FLUENY 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: 8003033
• Report Number: 9681442-2018-00190
• Device Sequence Number: 13525307
• Product Code: PFV
• UDI-Device Identifier: 04049519008615
• UDI-Public: (01)04049519008615
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: FEM10100
• Device Catalogue Number: FEM10100
• Device Lot Number: ANBX2681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR