MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. Fluency Plus Endovascular Stent Graft

Catalog Number	FEM10080
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f: the information provide by bd represents all 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
On (b)(6) 2026, a patient underwent a stent placement procedure using a fluency device.It was observed that the clear plastic knob on the back of the tuohy was loose and became disconnected, making stent deployment more difficult.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2026, a patient underwent a stent placement procedure using a fluency plus endovascular stent graft for the treatment of stenosis at the venous anastomosis via a left upper arm graft.During the procedure, while the stent was being deployed, it was observed that the clear plastic knob on the back of the tuohy was loose and became disconnected, making stent deployment more difficult.The patient is doing well, with no reported complications during or after the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 stent delivery system sample was not returned for evaluation and photos were not provided which leads to inconclusive results.In this case, it was reported that a 9fr introducer was used with a 0.035" guidewire for access, the tracking vessel was neither tortuous nor calcified, the lesion was pre-dilated and the device was flushed before use.Based on the provided information and as neither sample nor photos were provided, the investigation is closed with inconclusive results for detachment of the tuohy-borst and difficult to deploy.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 risks.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 preparation of the device the ifu state that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment".Regarding accessories the ifu states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.The ifu states "carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects.Do not use if the sterile barrier is compromised".H.4.Device manufacture date: unknown.B5, g3, h6 (result, conclusion).Section a through f: the information provide by bd represents all 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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25822439
• Report Number: 2020394-2026-01805
• Device Sequence Number: 21435472
• Product Code: PFV
• UDI-Device Identifier: 04049519008608
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Catalogue Number: FEM10080
• Device Lot Number: ANKX3281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown