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

Model Number	FEM14040
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A photo and image were provided for review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(expiry date: 12/2020), (b)(4).
Event or Problem Description
It was reported that during deployment, the healthcare provider (hcp) allegedly experienced some resistance and the stent graft was not flowering; however, the delivery system jumped forward and the stent graft deployed.It was further reported that upon stent graft placement, the tip broke off and migrated to the lung.Current patient status is unknown.
Event or Problem Description
It was reported that during deployment, the healthcare provider (hcp) allegedly experienced some resistance and the stent graft was not flowering; however, the delivery system jumped forward and the stent graft deployed.It was further reported that upon stent graft placement, the tip broke off and migrated to the lung.Current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: the lot 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 the specification prior to shipment.This is the first complaint reported for this lot.Investigation summary: based on the investigation of the returned delivery system, and the images provided it was confirmed that the deployment was difficult so that the tip of the outer catheter broke during the procedure and migrated to the lung.Images documenting the deployment were not provided so that stent graft jumping could not be confirmed.An indication for a manufacturing related issue could not be found.Based on the investigation the reported issue was confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu state: '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.' regarding the use of accessories the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)'; the packaging pictograms indicate a minimum introducer size of 10f.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.' (expiry date: 12/2020), (device code: 1069 - break).

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9526180
• Report Number: 2020394-2019-05858
• Device Sequence Number: 2777560
• Product Code: PFV
• UDI-Device Identifier: 04049519008684
• UDI-Public: (01)04049519008684
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FEM14040
• Device Catalogue Number: FEM14040
• Device Lot Number: ANBZ2025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1