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

Model Number FAS06050

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

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.

Event Description

It was reported that during a fistula de-clot procedure, a portion of the stent graft that was previously implanted allegedly broke off in the vessel.Reportedly, a snare was used to retrieve the stent graft fragment without any complications.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review was performed.The device history records have been reviewed and this 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 reported to date for this lot number and failure mode.The investigation is inconclusive for fracture as the device was not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The current ifu (instructions for use) states: stent graft size selection: special care must be taken to ensure that the appropriate size flair endovascular stent graft is selected.The stent graft body diameter should be approximately 1 mm larger than the synthetic av access graft diameter.The distal end of the flared configuration devices are approximately 4 mm larger in diameter than the body section.Faulty placement techniques may lead to failure in stent graft deployment.Do not kink the delivery system.The delivery system can function only after the red safety clip has been pulled off and the tuohy-borst valve is loosened.This should not be done until the stent graft is positioned across the lesion and is ready to be deployed.The safety and effectiveness of this device have not been established when used around a tight bend in a looped av graft.It is recommended to access the av graft at the venous side of the av graft or at the apex.Potential complications and adverse events: delivery system specific events that could be associated with clinical complications include bond joint failures, detachment of parts, incompatibility with accessory devices, premature deployment, inaccurate deployment, failure to deploy, high deployment forces, delivery system kinking, no visibility under fluoroscopy, inability to track to target location, and blood leakage from delivery system (hemostasis).Directions for use: after full stent graft deployment, wait a few seconds to allow for complete device expansion before removing the delivery system over the guidewire.If resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath.Visually confirm that the complete system has been removed.Inner catheter, distal tip, outer sheath, radiopaque marker band on outer sheath, distal radiopaque marker band on inner catheter, proximal radiopaque marker band on.(b)(4).

Event Description

It was reported that during a fistula de-clot procedure, a portion of the stent graft that was previously implanted allegedly broke off in the vessel.Reportedly, a snare was used to retrieve the stent graft fragment without any complications.There was no reported patient injury.

• Brand Name: FLAIR 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: 7085292
• MDR Text Key: 93821105
• Report Number: 2020394-2017-01693
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008912
• UDI-Public: (01)04049519008912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

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 Expiration Date: 09/29/2019
• Device Model Number: FAS06050
• Device Catalogue Number: FAS06050
• Device Lot Number: ANAW3584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• 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