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

Model Number	FEM08080
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
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 return of the device is pending.The investigation is currently under way.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 deployment of an endovascular stent graft at the venous anastamosis in a left arm fistula, the outer sheath allegedly broke and the stent graft would not deploy.It was further reported that the stent graft delivery system was removed and exchanged for another and the procedure was completed.There was no reported patient injury.
Event or Problem Description
It was reported that during deployment of an endovascular stent graft at the venous anastamosis in a left arm fistula, the outer sheath allegedly broke and the stent graft would not deploy.It was further reported that the stent graft delivery system was removed and exchanged for another and the procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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: the outer sheath was found to be elongated which indicated that high force was present which subsequently led to an outer sheath fracture.In addition the swivel nut distal to the handle was found to be detached which may indicated that high forces were present.No indication for a manufacturing related issue could be found.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: the instructions for use (ifu) which are applicable for this product were reviewed and it was found that the potential risks were sufficiently addressed.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." h11:section a through f - 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.

• 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: 7410202
• Report Number: 2020394-2018-00365
• Device Sequence Number: 19200218
• Product Code: PFV
• UDI-Device Identifier: 04049519008509
• UDI-Public: (01)04049519008509
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/07/2018

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: FEM08080
• Device Catalogue Number: FEM08080
• Device Lot Number: ANBW3309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1