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

Model Number FEM10080

Device Problems Positioning Failure (1158); Material Invagination (1336); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/03/2018

Event Type  malfunction  

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 device has been returned for evaluation.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 during preparation for procedure, upon opening the package, the distal tip of the endovascular catheter delivery system was identified allegedly detached rendering the device unusable.Reportedly, another device was used to perform the procedure.There was no patient contact.

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.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the sample evaluation a deployment failure could be confirmed.During evaluation testing the stent graft could not be deployed due to high release force and the outer sheath elongated.Increased friction was considered as reason for high deployment force and subsequent deployment failure.A tip detachment could not be confirmed as the tip was found to be invaginated.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 failure 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 risk.Regarding the use of accessories the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: 0.035" (0.889 mm) guidewire introducer sheath with appropriate inner diameter.In this case, an introducer sheath was not used.The ifu further states: 'carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects.' and 'examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.' the ifu further 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.' and '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.'.

Event Description

It was reported that the device was used bareback in the cephalic vein and allegedly failed to deploy after removing the safety clip.In addition it was alleged that the catheter tip was detached.Reportedly, another device 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
• MDR Report Key: 7760209
• MDR Text Key: 116376087
• Report Number: 2020394-2018-01396
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008608
• UDI-Public: (01)04049519008608
• 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
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: FEM10080
• Device Catalogue Number: FEM10080
• Device Lot Number: ANBW1743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1