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

Model Number	FEM07060
Medical Device Problem Codes	Premature Activation (1484); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a stent graft deployment procedure in a u-shaped a/v graft in the let upper arm, the stent graft allegedly had difficulty reaching the lesion via a bareback approach.It was further reported that it was removed and flushed.Furthermore, as it was being advanced to the lesion the end of the stent graft allegedly prematurely deployed.The device was successfully removed and another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft deployment procedure in a u-shaped a/v graft in the left upper arm, the stent graft allegedly had difficulty reaching the lesion via a bareback approach.It was further reported that it was removed and flushed.Furthermore, as it was being advanced to the lesion the end of the stent graft allegedly prematurely deployed.The device was successfully removed and another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 evaluation of the returned sample an advancing issue with a premature deployment as result could not be confirmed.The safety clip was not attached to the delivery system; it was not known when and how the stent graft partially deployed.A deformation or damage indicating advancing difficulty could not be found.No indication was found for a manufacturing related issue.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: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu recommends the use of an introducer sheath with appropriate inner diameter.In this case the treatment was performed bareback.The ifu states: "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit." 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".Also it is described that the safety clip should be removed when the stent graft is ready for deployment.In this case, the safety clip was not part of sample return.

• 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: 8229423
• Report Number: 2020394-2018-02301
• Device Sequence Number: 1827564
• Product Code: PFV
• UDI-Device Identifier: 04049519008448
• UDI-Public: (01)04049519008448
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 02/16/2021
• Device Model Number: FEM07060
• Device Catalogue Number: FEM07060
• Device Lot Number: ANCP2265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR