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

Model Number FEM10040

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event 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 an endovascular stent graft procedure to seal an aneurysm in the left arm transposed av fistula; basilica vein, the stent graft allegedly jumped and was implanted approximately 2cm from the intended placement site.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed to completely seal the aneurysm.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing related cause was considered.The device history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.The review showed no remarkable incidents occurred during the manufacturing process.No additional complaint has been previously reported for this lot number.Investigation summary: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample was provided for evaluation.Based on the available information and as no sample was returned the investigation was closed with inconclusive results.A definite root cause for the reported event could not be determined.However, the reported application represents an off label use of the device.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 states regarding increased deployment forces: "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 of the same size." 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." 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.¿ the reported application represents an off label use of the device.The ifu states that the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.

Event Description

It was reported that during an endovascular stent graft procedure to seal an aneurysm in the left arm transposed av fistula; basilica vein, the stent graft allegedly jumped and was implanted approximately 2cm from the intended placement site.Reportedly, the delivery system was removed without incident, and a second endovascular stent graft was deployed to completely seal the aneurysm.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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6895022
• MDR Text Key: 89399789
• Report Number: 2020394-2017-01224
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008585
• UDI-Public: (01)04049519008585
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: FEM10040
• Device Catalogue Number: FEM10040
• Device Lot Number: ANBQ4707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 75