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

Model Number FEM07040

Device Problem Material Perforation (2205)

Patient Problem Perforation of Vessels (2135)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records were provided to the manufacturer; however, four medical images were provided and are pending review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.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 Description

It was reported that after a successful endovascular stent graft placement procedure to cover a tight stenosis, the health care provider ran a post visual image and alleged it appeared there was a vessel dissection at the distal end of the stent graft.Therefore, a second endovascular stent graft was placed to cover the alleged perforation and complete the procedure.Reportedly, hemostasis was achieved, and the patient was fine post procedure.

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 physical sample was not returned.However, images were provided for evaluation.Based on the evaluation of the images provided, it was confirmed that a radiopaque marker was protruding sideways.In addition an accumulation of contrast medium outside the regular course of the vessel is displayed.Based on the images provided a manufacturing related issue could not be confirmed.Based on the information available and the evaluation of the provided images, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the currently valid labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.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: "post dilate the stent graft with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.".

Event Description

It was reported that after a successful endovascular stent graft placement procedure to cover a tight stenosis, the health care provider ran a post visual image and alleged it appeared there was a vessel dissection at the distal end of the stent graft.Therefore, a second endovascular stent graft was placed to cover the alleged perforation and complete the procedure.Reportedly, hemostasis was achieved, and the patient was fine post procedure.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7887757
• MDR Text Key: 120698392
• Report Number: 2020394-2018-01741
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008431
• UDI-Public: (01)04049519008431
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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
• Device Operator: Health Professional
• Device Model Number: FEM07040
• Device Catalogue Number: FEM07040
• Device Lot Number: ANBN2456
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR