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

Catalog Number	FEM06060
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure, the device allegedly unable to cross lesion in cephalic vein.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 delivery system was not returned for evaluation and photos were not provided which leads to inconclusive results.It was reported that a 9f introducer / 0.035" guidewire were used for access, the tracking vessel was tortuous but not calcified, the guidewire ran smoothly inside the delivery system, the lesion was pre-dilated, and the device was properly flushed prior to use.Based on available information, the investigation is closed with inconclusive results for failure to advance.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 sufficiently address the potential risks.The instructions for use state: "ensure the delivery catheter is straight and the stent graft extends a minimum of 10 mm distally (outflow) and 10 mm proximally (inflow) beyond the lesion into the non-diseased vessel".Regarding preparation of the device the instructions for use 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".About directions for use, the instructions for use states "pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter".Regarding accessories the instructions for use 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 8f and a 0.035" guidewire.H10: d4 (expiration date: 03/2026) h11: section a through f ¿ the information provided 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.H3 other text : device not returned.

• 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: 19246979
• Report Number: 2020394-2024-00604
• Device Sequence Number: 7309823
• Product Code: PFV
• UDI-Device Identifier: 04049519008394
• UDI-Public: (01)04049519008394
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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: FEM06060
• Device Lot Number: ANHQ0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 92 KG