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

Model Number FEM09100

Device Problems Fracture (1260); Use of Device Problem (1670); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 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 approximately three months ago, the stent graft was successfully placed in the basilic vein.Approximately a month later, during dialysis treatment, the dialysis needles had caught onto the stent during retraction of the needles, and allegedly pulled out a fragment of the stent through the basilic vein and the patient's skin.Reportedly, the access site was tight and there was resistance during removal of the needles and stent fragment.There was no reported patient injury.

Manufacturer Narrative

The lot number was not reported so that a detailed manufacturing review could not be performed.Therefore, it was not known whether the reported issue was a possible manufacturing issue.Based on the investigation of the returned piece of stent graft and the images provided a fragmentation of the stent graft could be confirmed.One radiopaque marker was returned as a torn-off piece which was also documented on the images provided.Images/movies documenting the entrapment leading to fracture during treatment have not been provided; the entrapped needle was not returned for evaluation.No indication was found for a production related issue.Based on the information available a definite root cause for the reported event could not be determined.In reviewing the applicable ifu, the potential issue was found addressed.The ifu states: 'the effects of direct cannulation on the stent graft have not been evaluated in a clinical study notify the patient that the stent graft should not be cannulated and applying pressure to the implant area should be avoided'.Holding of the system and correct motion during deployment were found described in the ifu.Furthermore, 'incompatibility with accessory devices perforation detachment of part stent graft fracture' were found mentioned as potential complications, and 'permanent deformation of device' was mentioned as an adverse event'.(b)(4).

Event Description

It was reported that a stent graft was successfully placed in the basilic vein.Approximately one month after stent graft placement during dialysis treatment.The dialysis needle had caught onto the stent during retraction of the needles, and allegedly pulled out a fragment of the stent graft through the basilic vein and the patient's skin.Reportedly, the access site was tight and there was resistance during removal of the needles and stent fragment.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: 6994237
• MDR Text Key: 91467655
• Report Number: 2020394-2017-01484
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008561
• UDI-Public: (01)04049519008561
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM09100
• Device Catalogue Number: FEM09100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 58 YR
• Patient Weight: 124