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

Model Number	FEM08120
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 12/2024.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly failed to deploy.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 investigation summary: the sample was received for evaluation.Based on the investigation performed in the laboratory, a partial deployment could be confirmed.The outer sheath was elongated, indicating high retraction forces applied to the device.Given the conditions of the system, a difficulty to advance could not be reproduced and the issue could not be confirmed.No manufacturing issues were identified.The system was flushed, and appropriate guidewire and introducer sheath were used.The vessel was not calcified but it was tortuous in nature.The device was straightened and the stent graft was placed in a straight section of the lumen prior to deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for partial deployment.Difficulty to advance the device could not be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe.(.).Regarding the precautions prior and during deployment the instructions for use states '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 and '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¿.The instructions for use states regarding the accessories 'the use of an appropriately sized introducer sheath is recommended; prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location'.¿the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: b5, d4 (expiry date: 12/2024), g3, h6 (device).H11: section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a stent placement procedure, two stents allegedly failed to deploy.The user experienced difficulties introducing the device.There was no reported patient injury.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15613759
• Report Number: 2020394-2022-00805
• Device Sequence Number: 5983261
• Product Code: PFV
• UDI-Device Identifier: 04049519008523
• UDI-Public: (01)04049519008523
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: FEM08120
• Device Catalogue Number: FEM08120
• Device Lot Number: ANFZ2843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: Black Or African American