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

Model Number	FEM07120
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or 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.(b)(4).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 an endovascular stent graft procedure in the axillary vein, the stent graft allegedly jumped 6mm and then partially deployed at the treatment site.It was further reported that the hand grip detached after the stent graft was successfully removed from the patient.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed to complete the procedure.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: on the basis of the returned stent graft delivery system, the reported deployment failure could be confirmed.The proximal luer was found to be detached which indicated that increased friction affected the delivery system during attempt of stent graft deployment and that a complete deployment was impossible.The reported stent graft jumping could not be reproduced because images have not been provided and because the stent graft was not fully deployed.No indication was found for manufacturing related issues.Labeling review: in reviewing the labeling supplied with 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." 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." 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." regarding storage and handling of the device the ifu states "store in a cool, dry place.Keep away from sunlight." and "carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects.Do not use if the sterile barrier is compromised.".
Event or Problem Description
It was reported that during an endovascular stent graft procedure in the axillary vein, the stent graft allegedly jumped 6mm and then partially deployed at the treatment site.It was further reported that the hand grip detached after the stent graft was successfully removed from the patient.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed to complete the procedure.There was no reported patient injury.

• 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: 7357597
• Report Number: 2020394-2018-00265
• Device Sequence Number: 13880729
• Product Code: PFV
• UDI-Device Identifier: 04049519008479
• UDI-Public: (01)04049519008479
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 01/05/2020
• Device Model Number: FEM07120
• Device Catalogue Number: FEM07120
• Device Lot Number: ANBN0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60