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

Model Number FEM10120

Device Problems Positioning Failure (1158); Fracture (1260); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer; however a photo was provided and a photo review will be performed.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).

Event Description

It was reported that during a bareback stent graft deployment procedure to treat two aneurysms through left upper arm access, the stent graft allegedly failed to deploy.Reportedly, the device was removed and another stent graft was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was performed.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.On the basis of the returned stent graft delivery system and the provided x-ray images, the alleged deployment failure could be confirmed.The stent graft was found partially released and the outer sheath was found to be elongated and fractured, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.Furthermore, the outer sheath was found perforated by stent graft strut, which made a stent graft deployment impossible.The reported application presents an off label use of the device.However, a definite root cause for the reported event could not be determined.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." 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." and "the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated." regarding the use of accessories the ifu states: "materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter".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." (b)(4).

Event Description

It was reported that during a bareback stent graft deployment procedure to treat two aneurysms through left upper arm access, the stent graft allegedly failed to deploy.Reportedly, the device was removed and another stent graft was used to complete the procedure.There was no reported patient injury.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6926630
• MDR Text Key: 89941305
• Report Number: 2020394-2017-01293
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008622
• UDI-Public: (01)04049519008622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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 Expiration Date: 12/23/2019
• Device Model Number: FEM10120
• Device Catalogue Number: FEM10120
• Device Lot Number: ANAZ3558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/07/2017
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1