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

Model Number	FEM14080
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned sample it could be confirmed that the delivery system could only partially deploy the stent graft.The outer sheath was found perforated by a stent graft strut in the sheath marker section which caused blockage of the system, and subsequent fracture of the outer sheath which made a complete stent graft deployment impossible.This event may have been associated with difficult anatomic conditions or challenging placement site leading to increased friction and subsequent damage of the outer sheath.In this case it was reported that the lesion was tight but the target lesion was predilated and no issue was encountered reaching the target lesion; however, the system was used bareback without introducer sheath.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.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: based on the lot number reported the following instructions for use (ifu) were supplied with the product: b05667.Currently valid: b05667 rev.5/04-16.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.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.' in regards to introducer sheath the ifu states: 'the use of an appropriately sized introducer sheath is recommended.' (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 a stent graft deployment of the subclavian vein, the stent graft was allegedly unable to deploy.The catheter was removed without issue and procedure was completed with another stent graft.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: 7516717
• Report Number: 2020394-2018-00675
• Device Sequence Number: 13759236
• Product Code: PFV
• UDI-Device Identifier: 04049519008707
• UDI-Public: (01)04049519008707
• 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
• Report Date (Section B): 05/15/2018

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: 07/07/2020
• Device Model Number: FEM14080
• Device Catalogue Number: FEM14080
• Device Lot Number: ANBU0951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR