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

Catalog Number FEM10060

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.However, a photo image was provided and a photo review will be performed.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.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 a stent placement procedure, the stent allegedly became stuck with a pta balloon while removing the device.Reportedly, after the balloon was removed, one of the radiopaque markers moved towards the center of the stent.An additional stent was required, overlapping the first deployed stent and completed 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.No relevant manufacturing process changes were implemented, that could have led to the event reported.Stent graft delivery system was returned for evaluation; no defects or any indication for an irregular stent deployment could be found.In addition, a photo of an x-ray image has been previously provided.Based on the photo the reported movement of one radiopaque marker towards the center of the stent graft could be confirmed.However, a definite root cause could not be identified.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: "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." regarding 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." and "do not use the device in patients where full expansion of an appropriately sized angioplasty balloon could not be achieved during pre-dilation." (product catalog: fem10060), (corporate lot: anzi2746), (b)(4).

Event Description

It was reported that in a stent placement procedure, a balloon allegedly stuck to a stent graft placed in the left cephalic arch during removal.As reported, the healthcare provider previously tried to efface a lesion in the cephalic arch with a balloon, but failed.Therefore the balloon catheter was removed and it was decided to place a stent graft.The balloon catheter was reinserted to post dilate proximally but when deflated and attempted to back the balloon in an effort to post dilate distally, the balloon would not move and appeared stuck to the stent graft.The healthcare provider managed to finally get it deployed; however at that point one of the radiopaque markers moved towards the center of the stent; when the balloon was removed, it was found to be torn.An additional balloon and an additional stent graft was required, overlapping the first deployed stent graft and completed 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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6795580
• MDR Text Key: 82938463
• Report Number: 2020394-2017-00970
• Device Sequence Number: 1
• Product Code: PFV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2018
• Device Catalogue Number: FEM10060
• Device Lot Number: ANZI2746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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: 133